Locally Advanced or Metastatic Solid TumorsPhase 1NCT07883577

A Study of RO7821657 in Participants With Solid Tumors

A Phase 1 study testing RO7821657 in people with Locally Advanced or Metastatic Solid Tumors, run by Hoffmann-La Roche.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

The aim of this study is to characterize the safety and tolerability of RO7821657, describe its pharmacokinetics (PK), and evaluate pharmacodynamic and biomarker effects to support selection of the recommended Phase 2 dose(s) (RP2D[s]) The study consists of two parts, namely Part 1 and Part 2: Part 1: Evaluation of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced or Metastatic Solid Tumors
What is being tested?: RO7821657
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 405 participants
Where: No sites listed yet
Study dates: 26 Oct 2026to 31 May 2030
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Life expectancy estimated by the Investigator to be ≥12 weeks.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; previously irradiated lesions are considered measurable if progression has been demonstrated in such lesions after the irradiation.
Availability of archival tumor tissue or tissue obtained from a fresh biopsy at screening if formalin-fixed paraffin-embedded [FFPE]-preserved archival tissue is not available. The archival tumor tissue should come from a core biopsy, a punch biopsy, an excisional biopsy, or a surgical specimen. Lymph node biopsy, bone biopsy (unless from soft tissue), or fine needle aspiration are unacceptable for submission. Lesions that are intended to be biopsied should not be counted as target lesions.
Adequate cardiovascular function:
New York Heart Association (NYHA) Heart Failure Class ≤ 1.
Agreement to adhere to the contraception requirements.

Who cannot join

Participants with active Central Nervous System (CNS) metastases.
Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted or checkpoint inhibitor therapy or surgical procedure, greater than CTCAE Grade 1 at the time of starting study treatment, except for alopecia and Grade 2 neuropathy.
Stable endocrine AEs managed with hormone replacement are permitted, including hypothyroidism on stable thyroid hormone replacement.
History of interstitial pulmonary disease, drug-induced pneumonitis, or evidence of active pneumonitis on screening computed tomography (CT) scan.
Participants with pulmonary miliary metastatic pattern (innumerable small lesions) or pulmonary lymphangitic carcinomatosis.
Active autoimmune disease that has required systemic treatment (except replacement treatment) within the last 2 years or any disease requiring immunosuppressive therapy while on study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: BP46447 https://forpatients.roche.com/ contact

888-662-6728

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry contact

About this study

Official title: A First In-Human, Multicenter, Phase I Clinical Study of RO7821657, a Protease Activated TCB Antibody That Targets CEACAM5, in Participants With Locally Advanced and/or Metastatic Solid Tumors

The study consists of two parts, namely Part 1 and Part 2:

Part 1: Evaluation of RO7821657 as monotherapy in participants with microsatellite-stable (MSS) colorectal cancer (CRC).

Part 2: Evaluation of RO7821657 as monotherapy in participants with non-squamous non-small cell lung cancer (NSCLC)

Conditions: Locally Advanced or Metastatic Solid Tumors
Being tested: RO7821657

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RO7821657Drug
Participants will receive RO7821657 as per the schedule described in the protocol.

Study groups in NCT07883577
Study group	Role	What they receive
Part 1A: Dose Escalation	Experimental	Participants with MSS CRC will receive multiple doses of RO7821657 in single and multiple participant cohorts. Receives: Drug: RO7821657
Part 1B: Backfill Cohorts	Experimental	Participants with MSS CRC will receive RO7821657 at dosing regimen selected based on data from Part 1A. Receives: Drug: RO7821657
Part 1C: Dose Expansion/Optimization	Experimental	Participants with MSS CRC will receive RO7821657 at dosing regimens selected based on data from Parts 1A and 1B. Receives: Drug: RO7821657
Part 2A: Abbreviated Dose Escalation	Experimental	Participants with non-squamous NSCLC will receive multiple doses of RO7821657 in multiple participant cohorts. Receives: Drug: RO7821657
Part 2B: Dose Expansion/Optimization	Experimental	Participants with non-squamous NSCLC will receive RO7821657 at dosing regimen selected based on data from Part 2A. Receives: Drug: RO7821657

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: Incidence and Severity of Adverse Events (AEs)
AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Any events of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Measured: Up to approximately 27 months
Part 2: Incidence and Severity of Adverse Events (AEs)
AEs will be graded according to NCI CTCAE v5.0. Any events of CRS and ICANS will be graded based on the ASTCT criteria
Measured: Up to approximately 27 months
Part 1A: Nature and Frequency of Dose-limiting Toxicities (DLTs)
Measured: From Cycle 1 (C1) Day 1 to the last day in C1 (Cycle 1 = 14-35 days)
Part 2A: Nature and Frequency of DLTs
Measured: From C1 Day 1 to the last day in C1 (Cycle 1 = 14-35 days)
Parts 1A and 1B: Recommended Phase 2 Dose (RP2D) Range of RO7821657
Measured: Up to approximately 27 months
Part 2A: RP2D Range of RO7821657
Measured: Up to approximately 27 months

Secondary outcomes (12)

Parts 1 and 2: Serum Concentration of RO7821657
Measured: Up to approximately 27 months
Parts 1 and 2: Objective Response Rate (ORR)
Measured: Up to approximately 27 months
Parts 1 and 2: Disease Control Rate (DCR)
Measured: Up to approximately 27 months
Parts 1 and 2: Duration of Response (DoR)
Measured: Up to approximately 27 months
Parts 1 and 2: Progression-free Survival (PFS)
Measured: Up to approximately 27 months
Parts 1 and 2: PFS Rate
Measured: At 6 months
Parts 1 and 2: Overall Survival (OS) Rate
Measured: At 6 months
Parts 1 and 2: Correlation of Baseline Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Tumor Expression With Clinical Activity
Measured: Up to approximately 27 months
Part 1B: Cluster of Differentiation 8 (CD8) Expression in Tumor Tissue
Measured: Up to approximately 27 months
Parts 1C and 2B: Percentage of Participants With Presence, Frequency, Severity and Interference of Symptomatic Treatment Toxicities as Assessed by NCI Patient-reported Outcomes (PRO)-CTCAE
Measured: Up to approximately 27 months
Parts 1C and 2B: Change From Baseline in Symptomatic Treatment Toxicities as Assessed by NCI PRO-CTCAE
Measured: Up to approximately 27 months
Parts 1C and 2B: Percentage of Participants Troubled by Treatment Symptoms, as Assessed by Single Item European Organisation for Research and Treatment of Cancer Item Library 46 (EORTC IL46)
Measured: Up to approximately 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Oct 202631 May 2030

First posted20 Oct 2026
Study start26 Oct 2026 (estimated)
Primary completion31 May 2030 (estimated)
Study completion31 May 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 405 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07883577
Sponsor's protocol ID: BP46447
Other IDs: 2026-526150-14-00
Status last verified: Oct 2026
First submitted: 14 Oct 2026
Last updated: 20 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Reference Study ID Number: BP46447 https://forpatients.roche.com/

888-662-6728

global-roche-genentech-trials@gene.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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