A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

Conditions

• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SAR445877 — DRUG
  Concentrate for solution for infusion
• Cetuximab — DRUG
  Solution for infusion
• ADG126 — DRUG
  Solution for infusion
• Bevacizumab — DRUG
  Solution for infusion
• Nivolumab — DRUG
  Solution for infusion
• Ipilimumab — DRUG
  Solution for infusion

Study Details

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. A multicohort dose expansion/dose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion/optimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable. Approximately 542 participants will be exposed to the study intervention: * approximately 123 participants in part 1, * up to 410 participants in expansion/dose optimization part (part 2) * and up to 9 participants in Japan cohort F.

Key Dates

First listed

Oct 18, 2022

Start date

Nov 29, 2022

Status verified

Jun 2026

Primary completion

Jan 19, 2027

Completion

Jun 28, 2028

Study Design

Enrollment

542 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: SAR445877 Escalation Phase (Part 1A)
  SAR445877 monotherapy will be administered intravenously in participants with solid tumors over a 14-day cycle.
• Experimental: SAR445877 Escalation Phase (Part1B)
  SAR445877 will be administered intravenously in combination with ADG126 in participants with advanced unresectable or metastatic melanoma, non-small cell lung cancer (NSCLC); renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), colorectal cancer (MSIH/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC).
• Experimental: SAR445877 Escalation Phase (Part 1C)
  SAR445877 will be administered intravenously in combination with bevacizumab in participants with metastatic colorectal cancer (CRC).
• Experimental: SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A)
  SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC).
• Experimental: SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A)
  SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC).
• Experimental: SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A)
  SAR445877 monotherapy will be administered intravenously in participants with hepatocellular carcinoma (HCC).
• Experimental: SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A)
  SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).
• Experimental: SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A)
  SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).
• Experimental: SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A)
  SAR445877 monotherapy will be administered intravenously IV in participants with immune infiltrated tumor type.
• Experimental: SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2B)
  SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC).
• Experimental: SAR445877 Expansion/optimization Phase: Cohort E2 (Part 2A)
  SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC).
• Experimental: SAR445877 Expansion/optimization Phase: Cohort E3 (Part 2B)
  SAR445877 will be administered intravenously in combination with cetuximab in participants with colorectal cancer.
• Experimental: SAR445877 Japan Cohort F
  SAR445877 monotherapy will be administered intravenously in participants with advanced unresectable or metastatic solid tumor, from Japan.
• Experimental: SAR445877 Expansion/Optimization Phase Cohort G1 (Part 2C)
  SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma.
• Experimental: SAR445877 Expansion/Optimization Phase Cohort G2 (Part 2C)
  SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma.
• Experimental: SAR445877 Expansion/Optimization Phase Cohort G3 (Part 2C)
  The Standard of Care (nivolumab and ipilimumab) will be administered intravenously in participants with metastatic melanoma.
• Experimental: SAR445877 Expansion/Optimization Phase Cohort H1 (Part 2D)
  SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC.
• Experimental: SAR445877 Expansion/Optimization Phase Cohort H2 (Part 2D)
  SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC.

Primary Outcome Measure

Dose escalation part 1A, 1C and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2 [ Time Frame: Cycles 1 & 2 - 14 days per cycle ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (9)

Find similar trials in Newark, DE

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