Clinical Trials List
Protocol NumberTCTLR-101
NCT Number(ClinicalTrials.gov Identfier)NCT04799054
Completed
2022-11-30 - 2027-03-31
Phase I/II
Recruiting4
ICD-10C69.40
Malignant neoplasm of unspecified ciliary body
ICD-10C69.41
Malignant neoplasm of right ciliary body
ICD-10C69.42
Malignant neoplasm of left ciliary body
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9190.0
Malignant neoplasm of eyeball, except conjunctiva, cornea, retina and choroid
Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
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Trial Applicant
WORLDWIDE CLINICAL TRIALS (TAIWAN) CO., LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chen-Chi Wang Division of Radiation Therapy
- CHENG-HSIEN LIN Division of Radiation Therapy
- 鄭皓升 Division of Radiation Therapy
- 林玟君 Division of Radiation Therapy
- ZHENG-WEI ZHOU Division of Radiation Therapy
- 趙勇全 Division of Radiation Therapy
- 李權 Division of Radiation Therapy
- 陳建志 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Fan Chang Division of Hematology & Oncology
- Mu-Hsin Chang Division of Hematology & Oncology
- 戴世光 Division of Hematology & Oncology
- Tsung-Lun Lee Division of Hematology & Oncology
- 朱本元 Division of Hematology & Oncology
- Tien-Hua Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chen-Yuan Lin Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Jui Yen
Co-Principal Investigator
- 顏志傑 Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumor
Objectives
Primary Objectives:
− To evaluate the safety and tolerability of TransCon TLR7/8 agonist monotherapy or in combination with pembrolizumab, and to define its maximum tolerated dose (MTD) and Phase 2 recommended dose (RP2D).
− Part 3 Leading Groups (Groups 3c and 3d): To evaluate the antitumor activity of TransCon TLR7/8 agonist monotherapy or in combination with pembrolizumab.
Secondary Objectives:
− To evaluate the antitumor activity of TransCon TLR7/8 agonist monotherapy or in combination with pembrolizumab.
− Plasma pharmacokinetic (PK) characterization of resiquimod, O-desethyl resiquimod, and total resiquimod (unlinked + linked) after IT dosing of TransCon TLR7/8 agonist monotherapy or in combination with pembrolizumab.
Exploratory Objectives:
− To evaluate TransCon TLR7/8 agonist monotherapy or in combination with pembrolizumab. Role in Hematology and Oncology: Calculating Pharmacokinetic (PD) Effects and Elucidating Mechanisms of Action
− Parts 1 & 2 and Parts 3, Groups 3a & 3b: Assessing the Association Between Efficacy Measurements Through Intratumoral Programmed Death-Ligand 1 (PD-L1) Performance (ORR assessed by the trial principal and ICR according to RECIST 1.1; ORR assessed by the trial principal according to itRECIST for overall tumor burden, injected and uninjected lesions)
− Part 3, Leading Groups 3c & 3d: Preoperative ORR assessed by the trial principal and ICR according to RECIST 1.1; Preoperative ORR assessed by the trial principal according to itRECIST for overall tumor burden, injected and uninjected lesions
− Part 3, Leading Groups 3c & 3d: Assessing the Association Between Local and Centrally Assessed pCR Through Intratumoral Programmed Death-Ligand 1 (PD-L1) Performance
− Part 1 and Part 2 and Part 3, Groups 3a and 3b: Assessing the association between efficacy measures by HPV status (as applicable and if available) (ORR assessed by the trial principal and ICR according to RECIST 1.1; ORR assessed by the trial principal according to itRECIST for overall tumor burden, injected and uninjected lesions)
− Part 3, Leading Groups 3c and 3d: Assessing the association between efficacy measures by HPV status (as applicable and if available) (pCR assessed by local and central authorities)
− Performing plasma PK characterization of resiquimod metabolites (if applicable)
Test Drug
注射劑
注射液
注射液
Active Ingredient
TransCon TLR7/8 Agonist
Pembrolizumab
Pembrolizumab
Dosage Form
270
279
279
Dosage
0.5 mg/mL
25 mg/mL
25 mg/mL
Endpoints
Primary Outcome Measures :
1.Safety and Tolerability [ Time Frame: Through study completion, expected average of 2 years ]
-Treatment emergent and treatment related adverse events (assessed by CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths
2.Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 (each cycle is 21 days) in Part 1 (monotherapy dose escalation) and Cycle 1 (the first cycle is 28 days and 21 days thereafter) in Part 2 (combination therapy dose escalation) ]
-Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
3.Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]
-To determine a recommended phase 2 dose of TransCon TLR7/8 Agonist and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
4.Response [ Time Frame: 9 weeks ]
-Evaluate the Pathologic complete response (pCR) per local assessment for pathology review anti-tumor activity of TransCon TLR7/8 Agonist in combination with pembrolizumab in the Neoadjuvant Cohorts
1.Safety and Tolerability [ Time Frame: Through study completion, expected average of 2 years ]
-Treatment emergent and treatment related adverse events (assessed by CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths
2.Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 (each cycle is 21 days) in Part 1 (monotherapy dose escalation) and Cycle 1 (the first cycle is 28 days and 21 days thereafter) in Part 2 (combination therapy dose escalation) ]
-Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
3.Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]
-To determine a recommended phase 2 dose of TransCon TLR7/8 Agonist and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
4.Response [ Time Frame: 9 weeks ]
-Evaluate the Pathologic complete response (pCR) per local assessment for pathology review anti-tumor activity of TransCon TLR7/8 Agonist in combination with pembrolizumab in the Neoadjuvant Cohorts
Inclution Criteria
the last dose of antibody and evidence of disease progression per investigator assessment before enrollment.
•Participants who have previously received an immune checkpoint inhibitor prior to enrollment must have any immune related toxicities resolved to ≤Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible.
•Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception.
•Participants who have previously received an immune checkpoint inhibitor prior to enrollment must have any immune related toxicities resolved to ≤Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible.
•Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception.
Exclusion Criteria
Exclusion Criteria:
Participants who have been previously treated with a TLR agonist (excluding topical agents for unrelated disease) are not eligible.
Other active malignancies within the last 2 years are excluded.
Active autoimmune diseases, regardless of need for immunosuppressive treatment at the time of screening, with the exception of patients well controlled on physiologic endocrine replacement.
Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation). Participants cannot start dosing on study until steroid dose is at or lower than 10 mg per day prednisone or equivalent.
Women who are breastfeeding or have a positive serum pregnancy test during screening or within 72 hours prior to C1D1 are not eligible.
Vaccination with live, attenuated vaccines within 4 weeks of enrollment.
Symptomatic central nervous system metastases.
Known bleeding disorder that is deemed to place the patient at unacceptable risk for bleeding complications from intratumoral injections or biopsies.
Known hypersensitivity to any component of TransCon TLR7/8 Agonist or pembrolizumab.
Any uncontrolled bacterial, fungal, viral, or other infection.
Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of first dosing on study is not allowed.
Significant cardiac disease
A marked baseline prolongation of QT/QTc (corrected QT) interval (e.g., repeated demonstration of a QTc interval >480 ms (National Cancer Institute NCI) Common Terminology Criteria for Adverse Events [CTCAE] grade 1) using Fredericia's QT correction formula.
A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, clinically significant hypokalemia, family history of Long QT Syndrome).
The use of concomitant medications that prolong the QT/QTc interval within 14 days of enrollment.
Positive for HIV or with active hepatitis B or C infection.
Participants who have been previously treated with a TLR agonist (excluding topical agents for unrelated disease) are not eligible.
Other active malignancies within the last 2 years are excluded.
Active autoimmune diseases, regardless of need for immunosuppressive treatment at the time of screening, with the exception of patients well controlled on physiologic endocrine replacement.
Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation). Participants cannot start dosing on study until steroid dose is at or lower than 10 mg per day prednisone or equivalent.
Women who are breastfeeding or have a positive serum pregnancy test during screening or within 72 hours prior to C1D1 are not eligible.
Vaccination with live, attenuated vaccines within 4 weeks of enrollment.
Symptomatic central nervous system metastases.
Known bleeding disorder that is deemed to place the patient at unacceptable risk for bleeding complications from intratumoral injections or biopsies.
Known hypersensitivity to any component of TransCon TLR7/8 Agonist or pembrolizumab.
Any uncontrolled bacterial, fungal, viral, or other infection.
Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of first dosing on study is not allowed.
Significant cardiac disease
A marked baseline prolongation of QT/QTc (corrected QT) interval (e.g., repeated demonstration of a QTc interval >480 ms (National Cancer Institute NCI) Common Terminology Criteria for Adverse Events [CTCAE] grade 1) using Fredericia's QT correction formula.
A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, clinically significant hypokalemia, family history of Long QT Syndrome).
The use of concomitant medications that prolong the QT/QTc interval within 14 days of enrollment.
Positive for HIV or with active hepatitis B or C infection.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
220 participants
