precemtabart tocentecan (M9140) / EMD Serono - LARVOL DELTA

Precemtabart tocentecan (M9140), an anti-CEACAM5 ADC with exatecan payload, in patients with metastatic colorectal cancer (mCRC): Results from the dose optimization of the phase 1 PROCEADE CRC-01 study. (ASCO 2025) - P1, P1/2 | " This global Phase 1 study in 3L adult patients with locally advanced/mCRC (ECOG PS ≤1; previous irinotecan therapy) evaluates clinical activity, safety, and tolerability of precemtabart tocentecan... These preliminary results corroborate the encouraging efficacy and safety data from the dose escalation part of the PROCEADE CRC-01 study, with no new relevant safety findings. ORR was higher at 2.8 mg/kg, with similar tolerability at both doses. The ORR of 24.1% (13.8% confirmed) at 2.8 mg/kg compares favorably with current monotherapy SoCs (ORRs 1-2%) and recent phase 3 data with trifluridine–tipiracil + bevacizumab (ORR 6.1%) in 3L+ mCRC."

Clinical • Metastases • P1 data • Anemia • Colorectal Cancer • Febrile Neutropenia • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CEACAM5

Precemtabart tocentecan (Precem-TcT) in patients with metastatic colorectal cancer (mCRC): Updated survival data from the Phase 1 PROCEADE®-CRC-01 study (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Colorectal Cancer • Oncology • Solid Tumor

Precemtabart tocentecan (Precem-TcT) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Results from the phase Ib/II PROCEADE-PanTumor PDAC substudy (ESMO-GI 2026) - P1, P1/2 | "Precem-TcT (M9140), the first anti-CEACAM5 antibody-drug conjugate (ADC) with an exatecan payload (topoisomerase 1 inhibitor), showed a predictable, manageable safety profile and promising efficacy in the phase 1 PROCEADE-CRC-01 study (NCT05464030) in pts with metastatic colorectal cancer (mCRC)...Conclusions Efficacy data in this highly refractory, mostly irinotecan-pretreated, mixed 2L/3L population benchmark favorably with current SoC for 2L mPDAC. Precem-TcT demonstrated a predictable safety profile in mPDAC, consistent with experience in mCRC. Further exploration of Precem-TcT in CEACAM5 high mPDAC is warranted."

Clinical • Metastases • P1/2 data • Pan tumor • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • CEACAM5

Precemtabart tocentecan (Precem-TcT, M9140), an anti-CEACAM5 antibody-drug conjugate (ADC), in patients with metastatic pancreatic ductal carcinoma (mPDAC): Results from the phase 1b/2 PROCEADE-PanTumor PDAC substudy. (ASCO 2026) - P1, P1/2 | "Funded by The healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) Clinical Trial Registration Number: NCT06710132 Background: CEACAM5 is overexpressed in many cancers, including PDAC, with limited expression in normal tissues. Precem-TcT, the first anti-CEACAM5 ADC with a TOP1i-payload reporting clinical data in patients with mPDAC, showed a predictable safety profile in this population, consistent with data from patients with mCRC. Efficacy data in this highly refractory, mostly irinotecan-pretreated 2L/3L population benchmark favorably with the current SoC for 2L mPDAC."

ADC • Clinical • Metastases • P1/2 data • Pan tumor • Colorectal Cancer • Gastric Cancer • Interstitial Lung Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CEACAM5

First-in-human trial of M9140, an anti-CEACAM5 antibody drug conjugate (ADC) with exatecan payload, in patients (pts) with metastatic colorectal cancer (mCRC). (ASCO 2024) - P1 | "Most pts were heavily pretreated (80% had ≥3 lines of prior treatment; 100% received irinotecan). M9140 demonstrated encouraging activity in heavily pretreated pts with advanced CRC, with a manageable and predictable safety profile. Contrary to approved ADCs with Top1i payloads, no ILD or ocular toxicities were observed. Evaluation of M9140 in mCRC continues in the dose expansion part of this study."

Clinical • Metastases • P1 data • Anemia • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Infectious Disease • Interstitial Lung Disease • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Septic Shock • Solid Tumor • Thrombocytopenia • CEACAM5

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (clinicaltrials.gov) - P1 | N=220 | Active, not recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Colorectal Cancer • Oncology • Solid Tumor • MSI

PROCEADE-CRC-03: A phase III study of precemtabart tocentecan (Precem-TcT), as monotherapy or plus bevacizumab, in patients with advanced metastatic colorectal cancer (mCRC) (ESMO-GI 2026) - P1 | "Precem-TcT (M9140) is the first anti-CEACAM5 antibody–drug conjugate (ADC) with the potent topoisomerase 1 inhibitor payload, exatecan...Adults with histologically confirmed mCRC, ECOG PS ≤1, prior exposure to fluoropyrimidine, irinotecan, oxaliplatin, and anti-VEGF therapy, and no more than 2 prior lines of therapy are eligible; selection is not based on CEACAM5 expression. Pts will be randomized (1:1:1) to receive Precem-TcT 2.8 mg Q3W (Arm 1) or Precem-TcT 2.8 mg Q3W + Bev 7.5 mg/kg Q3W (Arm 2) or trifluridine-tipiracil (FTD-TPI; 35 mg/m 2 , D1-D5, D8-12, BID, Q4W) + Bev (5 mg/kg, D1+D15, Q4W) (Arm 3)...An early futility analysis and an interim analysis of OS are planned. The study aims to enrol 1020 pts."

Clinical • Metastases • Monotherapy • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CEACAM5

Precemtabart tocentecan (Precem-TcT) in combination with bevacizumab in patients with metastatic colorectal cancer (mCRC): Results from the phase I PROCEADE-CRC-01 study (ESMO-GI 2026) - P1 | "Background Precem-TcT (M9140) is the first anti-CEACAM5 antibody–drug conjugate (ADC) with the topoisomerase 1 inhibitor payload, exatecan...Most patients (81.3%; n=13) had received ≥2 lines of treatment; 100% had received irinotecan, and 93.8% (n=15) anti-VEGF treatment; KRAS/BRAF mutation: 56.3%/0.0%...Efficacy results show antitumor activity of the combination, with an encouraging mPFS, benchmarking favorably with current SoC. A phase 3 study to evaluate Precem-TcT ± Bev vs trifluridine-tipiracil + Bev in 3L mCRC is planned."

Clinical • Combination therapy • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • CEACAM5 • KRAS

Precemtabart tocentecan: Initial data from P1/2 PROCEADE PanTumor trial (NCT06710132) for advanced solid tumors in H2 2026 (EMD Serono) - Jefferies DACH Corporate Conference in Baden

P1/2 data • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov) - P1/2 | N=250 | Recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2029 ➔ Jan 2028 | Trial primary completion date: Jan 2029 ➔ Jan 2028

Pan tumor • Trial completion date • Trial primary completion date • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov) - P1/2 | N=250 | Recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastric Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Efficacy and safety of antibody-drug conjugates in advanced colorectal cancer: A systematic review and single-arm meta-analysis of early-phase clinical trials. (ASCO 2026) - "ADCs evaluated included indusatumab vedotin, labetuzumab govitecan, trastuzumab deruxtecan, and precemtabart tocentecan... ADCs demonstrate modest antitumor activity in heavily pretreated advanced CRC with manageable but notable toxicity. The mPFS of 4.39 months and mOS of 10.1 months suggest potential clinical benefit in this population with limited therapeutic options. However, the high incidence of any-grade TRAEs (99.8%) and grade ≥3 TRAEs (55.2%) warrants careful patient selection and monitoring."

ADC • Metastases • Retrospective data • Review • Colorectal Cancer • Oncology • Solid Tumor

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov) - P1/2 | N=250 | Active, not recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Pan tumor • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • EGFR • HER-2

Merck Announces First Patient Dosed in Phase 3 Study for Investigational Antibody-Drug Conjugate in Colorectal Cancer (Businesswire) - "The study is evaluating precemtabart tocentecan (Precem‑TcT), a potential first‑in‑class investigational anti‑CEACAM5 antibody‑drug conjugate (ADC), for the treatment of metastatic colorectal cancer (mCRC)."

Trial status • Colorectal Cancer

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) (clinicaltrials.gov) - P3 | N=1020 | Not yet recruiting | Sponsor: EMD Serono Research & Development Institute, Inc.

New P3 trial • Colorectal Cancer • Oncology • Solid Tumor

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) (clinicaltrials.gov) - P3 | N=1020 | Recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

MS202329_0010: Phase 1b/2 Study of Anti-CEACAM5 ADC Precemtabart Tocentecan (M9140) in Participants With Advanced Gastric Cancer (Substudy GC) (clinicaltrialsregister.eu) - P1/2 | N=45 | Active, not recruiting | Sponsor: Merck Healthcare KGaA | Recruiting ➔ Active, not recruiting

Enrollment closed • Pan tumor • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CEACAM5 • HER-2

First Quarter 2026 and Recent Business Highlights: Precemtabart tocentecan (M9140) (OmniAb) - "At the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, pooled data on precemtabart tocentecan, a novel anti‑CEACAM5 antibody‑drug conjugate with a topoisomerase 1 inhibitor payload, from the PROCEADE-CRC-01 study in patients with metastatic colorectal cancer were presented that showed an objective response rate of 26.8% and median progression-free survival of 6.9 months. The overall safety profile was consistent with earlier data with no new or unexpected treatment-emergent adverse events. Merck KGaA indicated that based on Phase 1 data, it plans to advance precemtabart tocentecan directly to Phase 3 trials in metastatic colorectal cancer, with study initiation anticipated in the second or third quarter of 2026."

MSI-H • New P3 trial • P1 data • Colorectal Cancer • Microsatellite Instability

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov) - P1/2 | N=250 | Active, not recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Recruiting ➔ Active, not recruiting | Active, not recruiting ➔ Recruiting

Enrollment closed • Enrollment open • Pan tumor • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • EGFR • HER-2

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Trial completion date: Feb 2027 ➔ Oct 2026 | Trial primary completion date: Feb 2027 ➔ Oct 2026

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • MSI

Anti-CEACAM5 ADC Precemtabart Tocentecan (M9140) in Chinese Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Trial completion date: May 2026 ➔ Sep 2026 | Trial primary completion date: May 2026 ➔ Sep 2026

Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF • MSI

PROCEADE PanTumor: A Phase 1b/2, multicenter study of precemtabart tocentecan (M9140), an anti-CEACAM5 antibody-drug conjugate (ADC) with exatecan payload, in patients with advanced solid tumors (AACR 2025) - P1/2 | "The study is planned to be initiated at multiple sites globally, with an estimated enrollment of 250 patients. Clinical trial information: NCT06710132."

ADC • Clinical • First-in-human • Metastases • P1/2 data • Pan tumor • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CEACAM5 • EGFR • HER-2

Preclinical efficacy and safety of M9140, a novel antibody-drug conjugate (ADC) with topoisomerase 1 (TOP1) inhibitor payload targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5)‑expressing colorectal tumors (AACR 2024) - P1 | "Potency shift viability assays were conducted using two CRC cell lines, with zosuquidar used as multidrug resistance-1 (MDR-1) inhibitor. M9140 demonstrated high potency, strong antitumor activity, and bystander effect in preclinical models. The side effect profile in monkeys was favorable and in line with the expected toxicity of exatecan. Notably, ILD and ocular toxicity, which are known adverse effects of deruxtecan and maytansine-based ADCs respectively, were absent."

ADC • First-in-human • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • ABCB1 • CEACAM5 • TOP1

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Trial completion date: Aug 2026 ➔ Feb 2027 | Trial primary completion date: Aug 2026 ➔ Feb 2027

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • MSI

Precemtabart tocentecan (M9140) (Businesswire) - "Merck KGaA indicated that based on Phase 1 data, it plans to advance precemtabart tocentecan, a novel anti‑CEACAM5 antibody‑drug conjugate with topoisomerase 1 inhibitor payload, to Phase 3 trials in metastatic colorectal cancer, with the study initiation anticipated in 2026."

New P3 trial • Colorectal Cancer