A Phase 1/2, open-label, multicenter, dose escalation and dose expansion study of SAR442720 in combination with other agents in participants with advanced malignancies

Withdrawn

• Conditions: metastatic non small cell lungcancer; metastatic lung cancer; 10029107

• Registration Number: NL-OMON51317
• Lead Sponsor: Genzyme Europe BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

- Participants must be >= 18 years of age
- Histologically proven diagnosis of advanced solid tumors
- Participants must have one or more of the following molecular aberrations:
KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations
- Participants must have following molecular aberration (Part 3A and 3B): -
KRAS G12C mutation
- At least 1 measurable disease per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Woman of childbearing potential must agree to follow contraceptive guidance
- Capable of giving signed informed consent

Exclusion Criteria

- Predicted life expectancy <3 months.
- Primary central nervous system (CNS) tumors.
- Symptomatic or impending cord compression. Stable CNS disease is allowed.
- History of cerebrovascular stroke or transient ischemic attack within
previous 6 months.
- Prior solid organ or hematologic transplant.
- History or current retinal pigment epithelial detachment (RPED), central
serous retinopathy, retinal vascular occlusion (RVO), neovascular macular
degeneration
- Any clinically significant cardiac disease
- Active, known or suspected autoimmune disease
- History of or current interstitial lung disease or pneumonitis
- Receipt of a live-virus vaccination within 28 days, viral vaccine that do not
contain live virus within 7 days of planned treatment start. Seasonal flu
vaccines that do not contain live virus are permitted.
- Known infection with human immunodeficiency virus (HIV), known uncontrolled
hepatitis B infection, active tuberculosis, or severe infection requiring
parenteral antibiotic treatment.
- Inadequate hematologic, hepatic and renal function
- Known second malignancy
- Impairment of gastrointestinal function
- Any unstable or clinically significant concurrent medical condition that
would, in the opinion of the investigator, jeopardize the safety of a
participant, impact their expected survival through the end of the study
participation, and/or impact their ability to comply with the protocol.
- History of severe allergic reaction to any of the study intervention
components

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 3a:<br /><br>Incidence, nature and severity of TEAEs and SAEs according to NCI CTCAEv5.0 for<br /><br>the combination of SAR442720 and adagrasib.<br /><br>Part 3b:<br /><br>Objective response rate (ORR) defined as the percentage of participants with a<br /><br>confirmed complete response (CR) or partial response (PR) determined by the<br /><br>investigator, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part 3 of the study:<br /><br>Duration of response (DOR) of SAR442720 and adagrasib in all participants.<br /><br>Overall Response Rate (ORR) of the combination treatment with SAR442720 and<br /><br>adagrasib, based on RECIST v1.1<br /><br><br /><br>Part 3a:<br /><br>- plasma concentrations of SAR442720 and plasma concentrations of adagrasib<br /><br>- ORR of SAR442720 and adagrasib in all participants (based on RECIST v1.1).<br /><br><br /><br>Part 3b: the determination of<br /><br>- the duration of the response<br /><br>- the incidence of adverse reactions<br /><br>- the time to response (TTR)<br /><br>- the clinical benefit rate (CBR)<br /><br>- disease control rate (DCR)<br /><br>- progression free survival (PFS)</p><br>