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Carcinoma, Bronchogenic

Bronchial Neoplasms

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Maytansine

Tubulin Modulators

Antimitotic Agents

Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).

Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion

Tusamitamab ravtansine

Clinical Sciences & Operations

This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).

Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.

40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).

Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

PFS defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.

DCR defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1

DOR, defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first

Sanofi

Participants will receive tusamitamab ravtansine intravenous (IV) infusion until disease progression, unacceptable toxicity, the start of a new anti-cancer therapy, or the participant's or Investigator's decision to stop the treatment, whichever comes first.

Pharmaceutical form: Concentrated solution for intravenous (IV) administration; Route of administration: IV infusion

This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.

This is a single arm study in which participants will receive treatment with tusamitamab ravtansine until disease progression, unacceptable toxicity, the start of a new anti-cancer therapy, or the participant's or Investigator's decision to stop the treatment, whichever comes first.

Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors

To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as heart rate (HR).

To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QT interval.

To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QT interval corrected according to the Bazett's formula (QTcB).

To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QRS interval.

To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as PR interval.

Assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

The ORR, defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as the best overall response as determined by investigator/local radiologist review per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria

The DOR, defined as the time from the first documented evidence of confirmed complete response (CR) or partial response (PR) until progressive disease (PD) as determined by investigator/local radiologist review per RECIST v1.1 criteria or death (due to any cause), whichever comes first

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Antimetabolites

tusamitamab ravtansine every 2 weeks administered via intravenous infusion (IV)

tusamitamab ravtansine every 2 weeks combined with gemcitabine on Day 1, Day 8 and Day 15 every 4 weeks administered via intravenous infusion (IV)

Pharmaceutical form:Concentrated solution for IV;

Route of administration: IV infusion

tusamitamab ravtansine

Pharmaceutical form: Lyophilized powder for reconstitution or as a solution for infusion;

Route of administration: IV infusion

Primary Objective:

* For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC)
* For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine

Secondary Objectives:

* To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine
* To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine
* To assess the immunogenicity of tusamitamab ravtansine
* To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination

The expected duration of study intervention for participants may vary, based on progression date and the cohort; median expected duration of study per participant is estimated at 8 months for Cohort A/C and 6 months for Cohort B (up to 1 month for screening, a median of 4 or 2 months for treatment in Cohort A/C and Cohort B respectively, a median of 1 month for EOT, and follow-up visit 90 days after the last IMP administration).

Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors

Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors

Objective Response Rate (ORR) of tusamitamab ravtansine in mBC and tusamitamab ravtansine monotherapy and in combination with gemcitabine in mPAC, defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

Incidence of dose-limiting toxicites (DLTs) in the 28 Day DLT observation period (Cycle 1)

TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE v5.0.

DCR defined as the percentage of participants who have achieved CR, PR or stable disease as per RECIST v1.1.

DOR defined as the time from first documented evidence of CR or PR until progressive disease determined per RECIST v1.1 or death from any cause, whichever occurs first.

Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine.

Pharmacokinetic parameter of tusamitamab ravtansine.

Pharmacokinetic parameter of tusamitamab ravtansine. AUC0-14d calculated using the trapezoidal method.

Pharmacokinetic parameter of gemcitabine.

Pharmacokinetic parameter of gemcitabine metabolite.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA	NCT05245071	Non-squamous No...	Tusamitamab rav...	18 Years -	Sanofi
Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors	NCT05429762	Neoplasm	Tusamitamab rav...	18 Years -	Sanofi
Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors	NCT05429762	Neoplasm	Tusamitamab rav...	18 Years -	Sanofi
Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors	NCT04659603	Breast Cancer M... Pancreatic Carc...	tusamitamab rav... Gemcitabine	18 Years -	Sanofi
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA	NCT05245071	Non-squamous No...	Tusamitamab rav...	18 Years -	Sanofi

Spots Global Cancer Trial Database for tusamitamab ravtansine