NCT02187848

Evaluation of SAR408701 in Patients With Advanced Solid Tumors

Terminated Phase 1 Last updated 10 February 2025

What this trial tests

Phase 1 trial testing SAR408701 in Neoplasm Malignant in 254 participants. Terminated before completion.

Timeline

23 July 2014

Primary endpoint
10 November 2020

19 November 2024

Quick facts

Lead sponsor	Sanofi
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	254
Start date	23 July 2014
Primary completion	10 November 2020
Estimated completion	19 November 2024
Sites	20 locations across France, South Korea, Canada, United States, Spain

Drugs / interventions tested

• SAR408701 — full drug profile →

Conditions studied

• Neoplasm Malignant — all drugs for Neoplasm Malignant →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Neoplasm Malignant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objectives:

* To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).
* To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).
* To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1.

Secondary Objectives:

* To characterize the overall safety profile of SAR408701.
* To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives.
* To identify the recommended phase 2 dose (RP2D) of SAR408701.
* To assess the potential immunogenicity of SAR408701.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody drug conjugate: the "biological missile" for targeted cancer therapy.
   Fu Z, Li S, Han S, Shi C, et al · · 2022 · cited 1025× · PMID 35318309 · DOI 10.1038/s41392-022-00947-7
2. Antibody-drug conjugates in solid tumors: a look into novel targets.
   Criscitiello C, Morganti S, Curigliano G. · · 2021 · cited 169× · PMID 33509252 · DOI 10.1186/s13045-021-01035-z
3. Targeting cancer with antibody-drug conjugates: Promises and challenges.
   Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
4. Antibody structure and engineering considerations for the design and function of Antibody Drug Conjugates (ADCs).
   Hoffmann RM, Coumbe BGT, Josephs DH, Mele S, et al · · 2018 · cited 134× · PMID 29375935 · DOI 10.1080/2162402x.2017.1395127
5. DNA damaging agent-based antibody-drug conjugates for cancer therapy.
   Fu Y, Ho M. · · 2018 · cited 47× · PMID 30294716 · DOI 10.1093/abt/tby007
6. A comprehensive review on antibody-drug conjugates (ADCs) in the treatment landscape of non-small cell lung cancer (NSCLC).
   Abuhelwa Z, Alloghbi A, Nagasaka M. · · 2022 · cited 42× · PMID 35472631 · DOI 10.1016/j.ctrv.2022.102393
7. Antibody-drug conjugates in cancer therapy: mechanisms and clinical studies.
   He J, Zeng X, Wang C, Wang E, et al · · 2024 · cited 33× · PMID 39070179 · DOI 10.1002/mco2.671
8. Aberrant Glycosylation as Immune Therapeutic Targets for Solid Tumors.
   Matsumoto Y, Ju T. · · 2023 · cited 31× · PMID 37509200 · DOI 10.3390/cancers15143536