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New treatment option for Solid Tumor
Official title A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05584670
What this study is testing
What is SAR445877?
SAR445877 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors. The study will include 2 parts: A dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Dose escalation Part 1A and Japan Cohort F
- Participants with advanced unresectable or metastatic solid tumors for which, in the judgement of the investigator, no standard alternative therapy...
- Dose escalation Part 1B
- Participants with advanced unresectable or metastatic melanoma, NSCLC; renal cell carcinoma (RCC); HCC, colorectal cancer (MSI-H/dMMR), malignant...
- Dose escalation Part 1C
You likely can't join if
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Predicted life expectancy ≤3 months
- For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part...
- Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment
- Known active brain metastases or leptomeningeal metastases
- History of treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1...
See the full eligibility criteria
Who can join
- Dose escalation Part 1A and Japan Cohort F
- Participants with advanced unresectable or metastatic solid tumors for which, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant
- Dose escalation Part 1B
- Participants with advanced unresectable or metastatic melanoma, NSCLC; renal cell carcinoma (RCC); HCC, colorectal cancer (MSI-H/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). and...
- Dose escalation Part 1C
- Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer
- Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.
- Dose expansion/optimization Part 2 Cancer diagnosis:
- Participants in Cohorts A1 and A2 (Part 2A): Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
- Participants in Cohort B (part 2A): Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by American Association for the Study of Liver...
- Participants in Cohorts C1 and C2 (part 2A):
- Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 \& 3 gastro esophageal junction (GEJ) adenocarcinoma
- Disease with any CPS scoring. No need for CPS determination at local laboratory
- Participants must have MSI (metastatic microsatellite instability) or MMR (mismatch repair) status known or determined locally and must have non-MSI-H or proficient MMR (pMMR) disease to be eligible.
- Participants with unknown HER2/neu status must have their HER2/neu status determined locally. Participants with HER2/neu negative are eligible. Participants with HER2/neu positive tumors must have documentation of...
- Participants in Part 2A Cohorts E1 and E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer.
- Participants in Part 2A Cohorts E1, and E2 and Part 2B Cohort E3 MSI status: Participants must have MSI status known or determined locally and must have non- MSI-H disease to be eligible.
- Participants in Part 2A Cohorts E1, E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.
- Part 2C Cohorts G1, G2 and G3: Participants with histologically confirmed unresectable locally advanced or metastatic melanoma
- Prior anticancer therapy (For dose expansion/optimization Part 2 only)
- Participants in Cohorts A1 and A2: Participants must have received at least 1 systemic therapy for the metastatic setting and must not be amenable to the available SOC.
- Participants in Cohort B: Participants who have received at least 1 prior anticancer therapy, including an anti-PD1/PD-L1 containing regimen, and for whom have progressed after a primary or secondary resistance to an...
- Participants in Cohorts C1 and C2: Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care.
- Participants in Cohort D: Participants must have received at least 1 systemic therapy for their advanced/ metastatic setting and must not be amenable to the available SOC.
- Participants in Part 2A Cohorts E1 and E2 and Part 2D Cohorts H1 and H2 should have failed or relapsed on at least 2 prior regimens.
- Participants in cohort E3 should have failed or relapsed on at least 1 prior regimen. Participants who have received cetuximab or other anti-EGFR therapy as part of their prior line of treatment are eligible.
- Part 2C Cohorts G1, G2 and G3: Participants must have received at least one prior line of therapy for advanced/metastatic melanoma and/or does not have any standard of care (SoC) treatment option or decline or is...
- At least 1 measurable lesion per RECIST 1.1 criteria Part 1C and Part 2D: Adequate coagulation function for all participants. For participants receiving anti-coagulant therapy (except platelet anti-aggregates) the...
What rules you out
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Predicted life expectancy ≤3 months
- For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part 1.
- Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment
- Known active brain metastases or leptomeningeal metastases
- History of treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal...
- Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine
- Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
- Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.
- Organ transplant requiring immunosuppressive treatment
- Uncontrolled or active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency NOTE: Other Inclusion/Exclusion criteria may apply. The above...
The study team makes the final eligibility decision.
Where it's taking place
- Newark, Delaware, United States
- Iowa City, Iowa, United States
- Westwood, Kansas, United States
- Detroit, Michigan, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Rancagua, General Bernardo O'Higgins, Chile
- Santiago, Reg Metropolitana de Santiago, Chile
- Providencia, Chile
- Jerusalem, Jerusalem, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Tzrifin, Israel
- Kashiwa, Chiba, Japan
- Amsterdam, North Holland, Netherlands
- Rotterdam, South Holland, Netherlands
- Barcelona, Barcelona [Barcelona], Spain
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, Delaware, United States; Iowa City, Iowa, United States; Westwood, Kansas, United States; Detroit, Michigan, United States; Hackensack, New Jersey, United States; New York, New York, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.