Clinical trialPhase 2Terminated
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
- Outcome
- Stopped early. Results posted on ClinicalTrials.gov; not read here yetSponsor decision, the decision is not related to any safety concern. (Business decision)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 29 March 2021
- Ended
- 19 January 2025
- Enrollment
- 50 participants
- Sites
- 29
- Primary outcomes
- Objective Response Rate (ORR); Cohort C (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)
- Sponsor type
- Industry
- Results posted
- 25 March 2025
- Last update
- 1 October 2025
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Results posted on ClinicalTrials.gov; not read here yet. See them at the registry ↗
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Brief summary public domain (ClinicalTrials.gov)
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
Detailed description public domain (ClinicalTrials.gov)
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).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) [From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)]. Number, percentage of participants (95% Confidence Interval). Cohort A: mBC (n=6): 0 (0.00 to 45.93); Cohort B: mPAC (n=28): 3.6 (0.09 to 18.35); Cohort C: mPAC (n=16): 31.3 (11.02 to 58.66).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Cohort C (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs) [Cycle 1 (28 days)]. Count Of Participants, Participants. Cohort C: mPAC (n=3): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 86.6 weeks]. Count Of Participants, Participants. TEAEs: Cohort A: mBC (n=6): 6; Cohort B: mPAC (n=28): 28; Cohort C: mPAC (n=16): 16. TESAEs: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=28): 16; Cohort C: mPAC (n=16): 9.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Laboratory Abnormalities: Hematology/Coagulation and Clinical Chemistry [From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 86.6 weeks]. Count Of Participants, Participants. White blood cell decreased: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 1; Cohort C: mPAC (n=15): 0. Platelet count decreased: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 0; Cohort C: mPAC (n=15): 1. Neutrophil count decreased: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 1; Cohort C: mPAC (n=15): 2. Lymphocyte count decreased: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 0; Cohort C: mPAC (n=15): 2. International normalized ratio increased: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 1; Cohort C: mPAC (n=15): 1. Hypoalbuminemia: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 1; Cohort C: mPAC (n=15): 0. Hyponatremia: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 3; Cohort C: mPAC (n=15): 1. Hyperkalemia: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 1; Cohort C: mPAC (n=15): 0. Hypocalemia: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 2; Cohort C: mPAC (n=15): 0. Hypercalemia: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 0; Cohort C: mPAC (n=15): 2. Alanine aminotransferase increased: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 1; Cohort C: mPAC (n=15): 2. Aspartate aminotransferase increased: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 1; Cohort C: mPAC (n=15): 0. Alkaline phosphatase increased: Cohort A: mBC (n=6): 0; Cohort B: mPAC (n=27): 1; Cohort C: mPAC (n=15): 0. Total bilirubin increased: Cohort A: mBC (n=6): 1; Cohort B: mPAC (n=27): 2; Cohort C: mPAC (n=15): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)]. Median, months (95% Confidence Interval). Cohort A: mBC (n=6): 3.71 (1.314 to NA) [NA indicates that the upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events]; Cohort B: mPAC (n=28): 1.87 (1.643 to 2.267); Cohort C: mPAC (n=16): 4.73 (1.873 to NA) [NA indicates that the upper limit of 95% CI was not estimable due to insufficient number of participants with events].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Control Rate (DCR) [From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)]. Number, percentage of participants (95% Confidence Interval). Cohort A: mBC (n=6): 66.7 (22.28 to 95.67); Cohort B: mPAC (n=28): 28.6 (13.22 to 48.67); Cohort C: mPAC (n=16): 75.0 (47.62 to 92.73).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response (DOR) [From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)]. Median, months (95% Confidence Interval). Cohort B: mPAC (n=1): 4.11 (NA to NA) [NA indicates that the upper and lower limit of 95% CI were not estimable due to insufficient number of participants with events.]; Cohort C: mPAC (n=5): 7.26 (3.713 to NA) [NA indicates that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Treatment-emergent Anti-therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine [From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration [maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)]]. Count Of Participants, Participants. Cohort A: mBC (n=6): 2; Cohort B: mPAC (n=21): 5; Cohort C: mPAC (n=4): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Cohort C: Maximum Concentration Observed After Infusion (Cmax) of Tusamitamab Ravtansine [Cycle 1: Day 1: Start of infusion, end of infusion, 3, 72, 168, and 336 hours post-start of infusion (cycle duration: 28 days)]. Mean, microgram per milliliter (mcg/mL) (Standard Deviation). Cohort C: mPAC (n=8): 88.3 (17.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Cohort C: Area Under the Plasma Concentration Versus Time Curve Calculated Using the Trapezoidal Method From Time 0 to 14 Days (AUC0-14d) of Tusamitamab Ravtansine [Cycle 1: Day 1: Start of infusion, end of infusion, 3, 72, 168, and 336 hours post-start of infusion (cycle duration: 28 days)]. Mean, day*mcg/mL (Standard Deviation). Cohort C: mPAC (n=7): 473 (85.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Cohort C: Total Body Clearance From Plasma (CL) of Gemcitabine [Cycle 1: Days 1 and 8: Start of infusion, end of infusion, 0.25, 1, 1.5, and 2 hours post-start of infusion (cycle duration: 28 days)]. Mean, liter per hour (Standard Deviation). Cohort C: mPAC (n=3): 169 (93.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Cohort C: Cmax of Gemcitabine Metabolite (dFdU) [Cycle 1: Days 1 and 8: Start of infusion, end of infusion, 0.25, 1, 1.5, and 2 hours post-start of infusion (cycle duration: 28 days)]. Mean, mcg/mL (Standard Deviation). Cohort C: mPAC (n=3): 31.4 (7.27).