Clinical Trials List
Protocol NumberACT16432
2021-02-01 - 2027-12-31
Phase II
Recruiting3
ICD-10C25.9
Malignant neoplasm of pancreas, unspecified
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
ICD-9174.9
Malignant neoplasm of female breast, unspecified
ICD-9157.9
Malignant neoplasm of pancreas, part unspecified
Open-label, multi-cohort, Phase 2 trial, evaluating the efficacy and safety of SAR408701 in patients with CEACAM5-positive advanced solid tumors
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chi-Ching Chen Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
- Liang-Chih Liu Division of General Surgery
- Yu-Min Liao Division of Hematology & Oncology
- Yao-Chung Wu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-Jui Huang Digestive System Department
- Nai-Jung Chiang Digestive System Department
- Chia-Jui Yen Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- 姜乃榕 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ta-Chung Chao Division of Hematology & Oncology
- Jiun-I Lai Division of Hematology & Oncology
- Yi-Fang Tsai Division of General Surgery
- Chun-Yu Liu Division of Hematology & Oncology
- 馮晉榮 Division of General Surgery
- 邱仁輝 Division of General Surgery
- 賴亦貞 Division of Radiology
- 林燕淑 Division of General Surgery
- Chi-Cheng Huang Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
solid tumors
Objectives
In the first-in-human study TED13751, a cohort of heavily pretreated NSQ NSCLC patients with
CEACAM5-positive tum volving at least 50% of the tumor
cell population) has been treated with SAR408701 at the recommended dose of 100 mg/m² every
2 weeks. In the 64 treated patients, SAR408701 showed encouraging anti-tumor activity and was
associated with a response rate of 20.3% (95% CI: 12.27% to 31.71%); 28 participants (43.8%)
had stable disease. Patients were heavily pretreated with a median of 3 prior treatments (1 to
10 lines) for advanced disease, including anti-tubulin agents (60.9%) and anti-PD1/PD-L1
(70.3%).
Test Drug
SAR408701
Active Ingredient
SAR408701
Dosage Form
Vial
Dosage
125mg/25mL solution
Endpoints
To assess the anti-tumor activity of SAR408701 in mBC and mPAC
Inclution Criteria
I 01. Participant must be at least 18 years of age egal age of majority if
>18 years), at the time of signing the informed consent.
Type of participant and disease characteristics
I 02. Participants with at least one measurable lesion according to the RECIST v1.1 criteria that
has not been irradiated (ie, newly arising lesions in previously irradiated areas are
s, which
computed tomography (CT) (preferred) or magnetic
resonance imaging (MRI) scans.
I 03. Participants with ECOG performance status 0 to 1.
I 04. Evidence of metastatic disease.
Cohort A: mBC
I 05. Histological or cytologic diagnosis of breast cancer.
I 06. Expression of CEACAM5 as demonstrated prospectively by a centrally assessed IHC
0% of the tumor cell population in archival or
fresh tumor sample at the metastatic site (mandatory) including distant lymph nodes. At
least 5 fresh cut slides of formalin-fixed paraffin embedded (FFPE) tumor tissue sectioned
at a thickness of 4 to 5 µm are required. Cell collections (eg, from pleural effusion)
processed as FFPE blocks are acceptable. If less material is available, the participant could
still be considered eligible after discussion with the Sponsor, who may assess and confirm
that the available material is sufficient for key evaluations.
I 07. Have received at least 2 prior cytotoxic chemotherapy regimens for non-TNBC tumor type
or at least 1 for TNBC tumor type but not more than 4 in the locally recurrent or metastatic
setting.
I 08. Participants with non-TNBC tumor type (either at primary diagnostic or at metastatic site)
is defined as any estrogen receptor (ER) and/or progestero
staining by IHC) and/or HER2 positive (IHC [3+] or IHC [2+] and in situ hybridization
[ISH] positive based on single- -
disease status. Participants must be no longer eligible for hormonal therapy or HER2-
targeted therapy.
I 09. Participants with TNBC tumor type (either at primary diagnostic or at metastatic site) is
defined as ER/Progesterone receptor negative (<1% tumor staining by IHC), and HER2
nonoverexpressing by IHC (0, 1+) or ISH-negative based on single-probe average HER2
copy number <4.0 signals/cell or dual-probe HER2/CEP17 ratio <2.0 with an average
HER2 copy number <4.0 signals/cell.
>18 years), at the time of signing the informed consent.
Type of participant and disease characteristics
I 02. Participants with at least one measurable lesion according to the RECIST v1.1 criteria that
has not been irradiated (ie, newly arising lesions in previously irradiated areas are
s, which
computed tomography (CT) (preferred) or magnetic
resonance imaging (MRI) scans.
I 03. Participants with ECOG performance status 0 to 1.
I 04. Evidence of metastatic disease.
Cohort A: mBC
I 05. Histological or cytologic diagnosis of breast cancer.
I 06. Expression of CEACAM5 as demonstrated prospectively by a centrally assessed IHC
0% of the tumor cell population in archival or
fresh tumor sample at the metastatic site (mandatory) including distant lymph nodes. At
least 5 fresh cut slides of formalin-fixed paraffin embedded (FFPE) tumor tissue sectioned
at a thickness of 4 to 5 µm are required. Cell collections (eg, from pleural effusion)
processed as FFPE blocks are acceptable. If less material is available, the participant could
still be considered eligible after discussion with the Sponsor, who may assess and confirm
that the available material is sufficient for key evaluations.
I 07. Have received at least 2 prior cytotoxic chemotherapy regimens for non-TNBC tumor type
or at least 1 for TNBC tumor type but not more than 4 in the locally recurrent or metastatic
setting.
I 08. Participants with non-TNBC tumor type (either at primary diagnostic or at metastatic site)
is defined as any estrogen receptor (ER) and/or progestero
staining by IHC) and/or HER2 positive (IHC [3+] or IHC [2+] and in situ hybridization
[ISH] positive based on single- -
disease status. Participants must be no longer eligible for hormonal therapy or HER2-
targeted therapy.
I 09. Participants with TNBC tumor type (either at primary diagnostic or at metastatic site) is
defined as ER/Progesterone receptor negative (<1% tumor staining by IHC), and HER2
nonoverexpressing by IHC (0, 1+) or ISH-negative based on single-probe average HER2
copy number <4.0 signals/cell or dual-probe HER2/CEP17 ratio <2.0 with an average
HER2 copy number <4.0 signals/cell.
Exclusion Criteria
E 01. Medical condition requiring concomitant administration of a medication with a narrow
therapeutic window, that is metabolized by cytochrome P450 (CYP450) (see Appendix 10;
Section 10.10), and for which a dose reduction cannot be considered.
E 02. Medical conditions requiring concomitant administration of strong CYP3A inhibitor
(see Appendix 10; Section 10.10), unless it can be discontinued at least 2 weeks before the
first administration of study intervention.
E 03. Life expectancy less than 3 months.
E 04. Untreated brain metastases or history of leptomeningeal disease. Participants with
previously treated brain metastases may participate provided that:
- they are stable (ie, without evidence of progression by imaging for at least 4 weeks
prior to the first administration of study treatment, and any neurologic symptoms have
returned to baseline);
- there is no evidence of new or enlarging brain metastases;
- and the participant does not require any systemic corticosteroids to manage brain
metastases within 3 weeks prior to the first dose of study intervention.
E 05. Significant concomitant illness, including any severe medical condition that, in the opinion
of the Investigator or Sponsor, would impair the participant
interpretation of the results.
E 06. History within the last 3 years of an invasive malignancy other than the one treated in this
study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin
or carcinoma in situ of the cervix, or other local tumors considered cured by local
treatment.
E 07. History of known acquired immunodeficiency syndrome (AIDS) related illnesses or
known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or
active hepatitis A, B (defined as either positive HBsAg or positive hepatitis B viral
deoxyribonucleic acid [DNA] test above the lower limit of detection of the assay), or C
(defined as a known positive hepatitis C antibody result and known quantitative hepatitis C
virus [HCV] RNA results greater than the lower limits of detection of the assay) infection.
HIV serology will be tested at screening only for participants enrolled at German sites or in
any country where mandatory per local requirements.
E 08. Non-resolution of any prior treatment-related toxicity to < Grade 2 according to
NCI-CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled
with hormone replacement therapy (HRT).
E 09. Unresolved corneal disorder or any previous corneal disorder considered by an
ophthalmologist to predict higher risk of drug-induced keratopathy.
E 10. Use of contact lenses. Participants using contact lenses who are not willing to stop wearing
them for the duration of the study intervention are excluded.
therapeutic window, that is metabolized by cytochrome P450 (CYP450) (see Appendix 10;
Section 10.10), and for which a dose reduction cannot be considered.
E 02. Medical conditions requiring concomitant administration of strong CYP3A inhibitor
(see Appendix 10; Section 10.10), unless it can be discontinued at least 2 weeks before the
first administration of study intervention.
E 03. Life expectancy less than 3 months.
E 04. Untreated brain metastases or history of leptomeningeal disease. Participants with
previously treated brain metastases may participate provided that:
- they are stable (ie, without evidence of progression by imaging for at least 4 weeks
prior to the first administration of study treatment, and any neurologic symptoms have
returned to baseline);
- there is no evidence of new or enlarging brain metastases;
- and the participant does not require any systemic corticosteroids to manage brain
metastases within 3 weeks prior to the first dose of study intervention.
E 05. Significant concomitant illness, including any severe medical condition that, in the opinion
of the Investigator or Sponsor, would impair the participant
interpretation of the results.
E 06. History within the last 3 years of an invasive malignancy other than the one treated in this
study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin
or carcinoma in situ of the cervix, or other local tumors considered cured by local
treatment.
E 07. History of known acquired immunodeficiency syndrome (AIDS) related illnesses or
known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or
active hepatitis A, B (defined as either positive HBsAg or positive hepatitis B viral
deoxyribonucleic acid [DNA] test above the lower limit of detection of the assay), or C
(defined as a known positive hepatitis C antibody result and known quantitative hepatitis C
virus [HCV] RNA results greater than the lower limits of detection of the assay) infection.
HIV serology will be tested at screening only for participants enrolled at German sites or in
any country where mandatory per local requirements.
E 08. Non-resolution of any prior treatment-related toxicity to < Grade 2 according to
NCI-CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled
with hormone replacement therapy (HRT).
E 09. Unresolved corneal disorder or any previous corneal disorder considered by an
ophthalmologist to predict higher risk of drug-induced keratopathy.
E 10. Use of contact lenses. Participants using contact lenses who are not willing to stop wearing
them for the duration of the study intervention are excluded.
The Estimated Number of Participants
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Taiwan
6 participants
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Global
64 participants
