Clinical Trials List
Protocol NumberB8011007
Completed
2020-03-13 - 2024-02-15
Phase I/II
Recruiting2
Terminated2
ICD-10D38.5
Neoplasm of uncertain behavior of other respiratory organs
ICD-10D38.6
Neoplasm of uncertain behavior of respiratory organ, unspecified
ICD-9235.9
Neoplasm of uncertain behavior of other and unspecified respiratory organs
An open phase 1b/2 trial to evaluate the pharmacokinetics, safety, efficacy and pharmacodynamics of PF-06801591 (PD-1 inhibitor) among participants in advanced malignancies
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Sponsor
pfizer
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 蕭慈慧 Division of Thoracic Medicine
- Heng-Sheng Chao Division of Thoracic Medicine
- Hsu-ching Huang Division of Thoracic Medicine
- Yung-Hung Luo Division of Thoracic Medicine
- Chao-Hua Chiu 未分科
- Chi-Lu Chiang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Inn-Wen Chong Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- KUAN-LI WU Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
2 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
NSCLC
Objectives
To evaluate the pharmacokinetics, safety, efficacy and pharmacodynamics of PF-06801591 (PD-1 inhibitor) in participants with advanced malignant tumors.
Test Drug
PF-06801591
Active Ingredient
PF-06801591
Dosage Form
Solution for injection
Dosage
150 mg/mL
Endpoints
Compare the exposure doses of PF-06801591 600 mg SC Q6W and 300 mg SC Q4W in terms of the concentration-time of the dosing interval (τ)
Ctrough analysis of area under the curve (AUCτ) and steady state
Ctrough analysis of area under the curve (AUCτ) and steady state
Inclution Criteria
Inclusion conditions:
1. Participants must be at least 18 years old when signing the subject consent form (participants participating in this trial in Taiwan must be at least 20 years old).
2. The histological or cytological diagnosis is NSCLC.
a. All participants who enter this trial must have at least one lesion that is defined as measurable according to the Response Evaluation Criteria for Solid Tumors (RECIST) Version 1.1, and the lesion has not previously been irradiated (it is allowed to show clear deterioration after radiation therapy) Lesions).
b. Participants must have a confirmed stage III diagnosis, indicating that the participant is not suitable for surgical resection or definitive chemoradiation therapy, or has stage IV NSCLC (according to the 8th edition of the International Association for the Study of Lung Cancer [IASLC] classification)
c. Activated epithelial cell growth factor receptor (EGFR) mutations (detection is required if the status is unknown), mutations of the known v-raf mouse sarcoma virus oncogene homolog B1 (BRAF), and anaplasticity are not allowed Lymphoma stimulus (ALK) or c-ros oncogene 1 (ROS1) translocation/recombination (test if unknown).
d. Participants with known tumors that are PD-L1 positive (tumor ratio score [TPS] greater than or equal to 1%) or unknown participants are eligible (if unknown, no testing is required).
e. It is allowed to have performed at most 1 line therapy in the context of advanced or metastatic disease.
If recurrence or metastatic disease occurs during treatment or within 6 months after receiving the last dose of the drug, lead adjuvant/adjuvant therapy will be regarded as the first-line treatment for advanced or metastatic disease.
According to national regulations, participants should actively refuse chemotherapy or other standard therapies when applicable, including anti-PD-1 or PD-L1 drugs approved for the treatment of advanced disease (unresectable or metastatic).
f. Participants should not have received previous treatments containing PD-1/PD-L1 drugs.
3. The ECOG physical fitness scale score of the United States East Coast Cancer Clinical Research Cooperative (ECOG) is 0 or 1 point.
4. The life expectancy is estimated to be at least 3 months.
5. There is sufficient bone marrow function.
a. ANC is greater than or equal to 1,500/mm3 or greater than or equal to 1.5 × 109/L;
b. Platelets are greater than or equal to 75,000/mm3 or greater than or equal to 75 × 109/L;
c. Heme greater than or equal to 9 g/dL
6. Have adequate kidney function.
a. Participants whose estimated creatinine clearance rate is greater than or equal to 50 mL/min shall be calculated using the standard method of the institution. If in doubt, a 24-hour urine collection test can be used to more accurately estimate the creatinine clearance rate.
7. Have sufficient liver function.
b. Total serum bilirubin is less than or equal to 1.5 × upper limit of normal (ULN), unless the participant has proven Gibb’s syndrome;
c. Aspartic acid transamidation 酶 and alanine transamidation酶 (aspartic acid transamidation酶 [AST] and alanine transamidation酶 [ALT]) less than or equal to 2.5 × ULN; if the tumor invades the liver, it is less than or equal to 5.0 × ULN;
d. Alkaline phosphate 酶 less than or equal to 2.5 × ULN (if there is bone or liver metastasis, less than or equal to 5 × ULN)
8. The pre-administration assessment according to the Time of Activity (SoA) should also meet all inclusion requirements.
9. The acute effect of any previous treatment has been alleviated to the baseline severity or Common Adverse Event Evaluation Criteria (CTCAE) level is less than or equal to 1, but does not include adverse events (AE) judged by the trial host as not posing a safety risk.
10. Male or female.
A male participant is eligible to participate if he agrees to follow the following during the intervention period and within 6 months after the intervention of the last dose of the trial.
Sperm donation is prohibited
And meets one of the following:
As his preferred and usual lifestyle, he avoids intercourse with the opposite sex (long-term and continuous abstinence) and agrees to maintain abstinence.
or
Must agree to use the contraceptive/barrier method detailed below
Agree to use male condoms, and you should understand the benefits of female partners using highly effective contraceptive methods, because condoms may break or leak during intercourse with a fertile female who is not currently pregnant
Female participants who are not pregnant or breastfeeding, including those who intend to interrupt breastfeeding, and meet at least one of the following conditions are eligible to participate in the trial:
Not a Woman of Reproductive Ability (WOCBP)
or
For WOCBP and use highly effective contraceptive methods (failure rate <1% per year) during the intervention period and for at least 6 months after the last dose of the trial intervention (the time required to exclude any reproductive safety risks from the trial intervention), and It is best to use a method with low user dependence, as described in Appendix 4; and agree not to donate eggs (eggs, oocytes) for reproductive purposes during this period. If the participant uses a highly effective method that is highly dependent on the user, this contraceptive method must be used together with the second effective contraceptive method. See Appendix 4 for details. The trial host should evaluate the relationship between the effectiveness of the contraceptive measure and the intervention of the first dose of the trial.
The trial host must be responsible for reviewing medical history, menstrual history, and recent sexual behavior to reduce the risk of including women who have not tested for early pregnancy.
11. Be able to provide a signed subject consent form, which includes the cooperation subject consent form (ICF) and the requirements and restrictions listed in this trial plan
12. Participants are willing and able to cooperate with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other test procedures.
1. Participants must be at least 18 years old when signing the subject consent form (participants participating in this trial in Taiwan must be at least 20 years old).
2. The histological or cytological diagnosis is NSCLC.
a. All participants who enter this trial must have at least one lesion that is defined as measurable according to the Response Evaluation Criteria for Solid Tumors (RECIST) Version 1.1, and the lesion has not previously been irradiated (it is allowed to show clear deterioration after radiation therapy) Lesions).
b. Participants must have a confirmed stage III diagnosis, indicating that the participant is not suitable for surgical resection or definitive chemoradiation therapy, or has stage IV NSCLC (according to the 8th edition of the International Association for the Study of Lung Cancer [IASLC] classification)
c. Activated epithelial cell growth factor receptor (EGFR) mutations (detection is required if the status is unknown), mutations of the known v-raf mouse sarcoma virus oncogene homolog B1 (BRAF), and anaplasticity are not allowed Lymphoma stimulus (ALK) or c-ros oncogene 1 (ROS1) translocation/recombination (test if unknown).
d. Participants with known tumors that are PD-L1 positive (tumor ratio score [TPS] greater than or equal to 1%) or unknown participants are eligible (if unknown, no testing is required).
e. It is allowed to have performed at most 1 line therapy in the context of advanced or metastatic disease.
If recurrence or metastatic disease occurs during treatment or within 6 months after receiving the last dose of the drug, lead adjuvant/adjuvant therapy will be regarded as the first-line treatment for advanced or metastatic disease.
According to national regulations, participants should actively refuse chemotherapy or other standard therapies when applicable, including anti-PD-1 or PD-L1 drugs approved for the treatment of advanced disease (unresectable or metastatic).
f. Participants should not have received previous treatments containing PD-1/PD-L1 drugs.
3. The ECOG physical fitness scale score of the United States East Coast Cancer Clinical Research Cooperative (ECOG) is 0 or 1 point.
4. The life expectancy is estimated to be at least 3 months.
5. There is sufficient bone marrow function.
a. ANC is greater than or equal to 1,500/mm3 or greater than or equal to 1.5 × 109/L;
b. Platelets are greater than or equal to 75,000/mm3 or greater than or equal to 75 × 109/L;
c. Heme greater than or equal to 9 g/dL
6. Have adequate kidney function.
a. Participants whose estimated creatinine clearance rate is greater than or equal to 50 mL/min shall be calculated using the standard method of the institution. If in doubt, a 24-hour urine collection test can be used to more accurately estimate the creatinine clearance rate.
7. Have sufficient liver function.
b. Total serum bilirubin is less than or equal to 1.5 × upper limit of normal (ULN), unless the participant has proven Gibb’s syndrome;
c. Aspartic acid transamidation 酶 and alanine transamidation酶 (aspartic acid transamidation酶 [AST] and alanine transamidation酶 [ALT]) less than or equal to 2.5 × ULN; if the tumor invades the liver, it is less than or equal to 5.0 × ULN;
d. Alkaline phosphate 酶 less than or equal to 2.5 × ULN (if there is bone or liver metastasis, less than or equal to 5 × ULN)
8. The pre-administration assessment according to the Time of Activity (SoA) should also meet all inclusion requirements.
9. The acute effect of any previous treatment has been alleviated to the baseline severity or Common Adverse Event Evaluation Criteria (CTCAE) level is less than or equal to 1, but does not include adverse events (AE) judged by the trial host as not posing a safety risk.
10. Male or female.
A male participant is eligible to participate if he agrees to follow the following during the intervention period and within 6 months after the intervention of the last dose of the trial.
Sperm donation is prohibited
And meets one of the following:
As his preferred and usual lifestyle, he avoids intercourse with the opposite sex (long-term and continuous abstinence) and agrees to maintain abstinence.
or
Must agree to use the contraceptive/barrier method detailed below
Agree to use male condoms, and you should understand the benefits of female partners using highly effective contraceptive methods, because condoms may break or leak during intercourse with a fertile female who is not currently pregnant
Female participants who are not pregnant or breastfeeding, including those who intend to interrupt breastfeeding, and meet at least one of the following conditions are eligible to participate in the trial:
Not a Woman of Reproductive Ability (WOCBP)
or
For WOCBP and use highly effective contraceptive methods (failure rate <1% per year) during the intervention period and for at least 6 months after the last dose of the trial intervention (the time required to exclude any reproductive safety risks from the trial intervention), and It is best to use a method with low user dependence, as described in Appendix 4; and agree not to donate eggs (eggs, oocytes) for reproductive purposes during this period. If the participant uses a highly effective method that is highly dependent on the user, this contraceptive method must be used together with the second effective contraceptive method. See Appendix 4 for details. The trial host should evaluate the relationship between the effectiveness of the contraceptive measure and the intervention of the first dose of the trial.
The trial host must be responsible for reviewing medical history, menstrual history, and recent sexual behavior to reduce the risk of including women who have not tested for early pregnancy.
11. Be able to provide a signed subject consent form, which includes the cooperation subject consent form (ICF) and the requirements and restrictions listed in this trial plan
12. Participants are willing and able to cooperate with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other test procedures.
Exclusion Criteria
Exclude conditions:
1. Participants who are known to suffer from symptomatic brain metastases and need to use steroids. Participants previously diagnosed with brain metastases, if they have completed their treatment before joining the trial and recovered from the acute effects of radiotherapy or surgery, have terminated corticosteroid therapy for these metastases for at least 4 weeks, and have maintained neurological stability6 Zhou (need to be confirmed by MRI), is eligible to participate.
2. Participants with a history or complications of interstitial lung disease (ILD).
3. Participants had any other active malignant tumors within 3 years prior to enrollment, unless it was basal cell or squamous cell skin cancer with appropriate treatment, or carcinoma in situ.
4. Clinically significant multiple or severe drug allergies, inability to tolerate topical corticosteroids, or severe post-treatment allergic reactions (including but not limited to severe erythema multiforme, linear immunoglobulin A [IgA] skin diseases, toxic epidermis Necrolysis and exfoliative dermatitis)
5. Participants who are known to have active, poorly controlled bacterial, fungal or viral infections, including hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infection seropositive.
6. Male participants had heart rate QTc> 450 msec, female participants had QTc> 470 msec, or participants with right bundle branch block had QTc> 480 msec, and the Q-T interval was corrected.
7. Patients with high blood pressure that cannot be controlled with drugs even though the best drug therapy has been applied (for example, systolic blood pressure> 150 mmHg and diastolic blood pressure> 90 mmHg).
8. Known or suspected allergy to the active ingredients or excipients of the test drug.
9. Immune-mediated AEs greater than or equal to level 3 (including AST/ALT elevations and cytokine release syndrome [CRS] that have been identified as drug-related) have been identified as related to previous immunomodulatory therapies (such as immune Checkpoint inhibitors, co-stimulants, etc.), and immunosuppressive therapy is required (only for phase 1b).
10. Screening or C1D1 serum or urine pregnancy test (for women with fertility) is positive.
Previous/combined therapy
11. Receive major surgery within 3 weeks before entering the trial.
12. Receive radiotherapy within 3 weeks before entering the trial.
13. Receive anti-cancer therapy containing monoclonal antibodies within 28 days before entering the trial, or receive anti-cancer therapy containing small molecules (targeted therapy or chemotherapy) within 14 days before entering the trial.
14. It is forbidden to vaccinate live attenuated vaccines within 4 weeks before random assignment; however, inactivated vaccines are acceptable.
Previous/simultaneous clinical trial experience
15. Participate in other experimental active treatments involving experimental drugs within 4 weeks before entering the trial.
Other exclusions
16. There are other acute or chronic medical or mental conditions, including recent (in the past year) or current suicidal intention or behavior or abnormal laboratory test results, which may increase the risk associated with trial participation or use of experimental products or It may interfere with the interpretation of the test results, and according to the judgment of the test host, the participants will not be suitable for entering the test.
The staff of the test host institution and their family members who directly perform the test, the staff of the test institution supervised by the test host in other ways, or Pfizer employees directly involved in the test execution, including their family members.
1. Participants who are known to suffer from symptomatic brain metastases and need to use steroids. Participants previously diagnosed with brain metastases, if they have completed their treatment before joining the trial and recovered from the acute effects of radiotherapy or surgery, have terminated corticosteroid therapy for these metastases for at least 4 weeks, and have maintained neurological stability6 Zhou (need to be confirmed by MRI), is eligible to participate.
2. Participants with a history or complications of interstitial lung disease (ILD).
3. Participants had any other active malignant tumors within 3 years prior to enrollment, unless it was basal cell or squamous cell skin cancer with appropriate treatment, or carcinoma in situ.
4. Clinically significant multiple or severe drug allergies, inability to tolerate topical corticosteroids, or severe post-treatment allergic reactions (including but not limited to severe erythema multiforme, linear immunoglobulin A [IgA] skin diseases, toxic epidermis Necrolysis and exfoliative dermatitis)
5. Participants who are known to have active, poorly controlled bacterial, fungal or viral infections, including hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infection seropositive.
6. Male participants had heart rate QTc> 450 msec, female participants had QTc> 470 msec, or participants with right bundle branch block had QTc> 480 msec, and the Q-T interval was corrected.
7. Patients with high blood pressure that cannot be controlled with drugs even though the best drug therapy has been applied (for example, systolic blood pressure> 150 mmHg and diastolic blood pressure> 90 mmHg).
8. Known or suspected allergy to the active ingredients or excipients of the test drug.
9. Immune-mediated AEs greater than or equal to level 3 (including AST/ALT elevations and cytokine release syndrome [CRS] that have been identified as drug-related) have been identified as related to previous immunomodulatory therapies (such as immune Checkpoint inhibitors, co-stimulants, etc.), and immunosuppressive therapy is required (only for phase 1b).
10. Screening or C1D1 serum or urine pregnancy test (for women with fertility) is positive.
Previous/combined therapy
11. Receive major surgery within 3 weeks before entering the trial.
12. Receive radiotherapy within 3 weeks before entering the trial.
13. Receive anti-cancer therapy containing monoclonal antibodies within 28 days before entering the trial, or receive anti-cancer therapy containing small molecules (targeted therapy or chemotherapy) within 14 days before entering the trial.
14. It is forbidden to vaccinate live attenuated vaccines within 4 weeks before random assignment; however, inactivated vaccines are acceptable.
Previous/simultaneous clinical trial experience
15. Participate in other experimental active treatments involving experimental drugs within 4 weeks before entering the trial.
Other exclusions
16. There are other acute or chronic medical or mental conditions, including recent (in the past year) or current suicidal intention or behavior or abnormal laboratory test results, which may increase the risk associated with trial participation or use of experimental products or It may interfere with the interpretation of the test results, and according to the judgment of the test host, the participants will not be suitable for entering the test.
The staff of the test host institution and their family members who directly perform the test, the staff of the test institution supervised by the test host in other ways, or Pfizer employees directly involved in the test execution, including their family members.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
90 participants
