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

Study Identifier:
BP46447
CT.gov Identifier:
NCT07883577
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2026-526150-14-00
Study Contact Information:
N/A
Will Be Recruiting

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Study 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])

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1A: Dose Escalation
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Drug: Participants with MSS CRC will receive multiple doses of RO7821657 in single and multiple participant cohorts.
Drug: Drug: RO7821657
Drug: Participants will receive RO7821657 as per the schedule described in the protocol.
Drug: EXPERIMENTAL: Part 1B: Backfill Cohorts
Drug: Participants with MSS CRC will receive RO7821657 at dosing regimen selected based on data from Part 1A.
Drug: EXPERIMENTAL: Part 1C: Dose Expansion/Optimization
Drug: Participants with MSS CRC will receive RO7821657 at dosing regimens selected based on data from Parts 1A and 1B.
Drug: EXPERIMENTAL: Part 2A: Abbreviated Dose Escalation
Drug: Participants with non-squamous NSCLC will receive multiple doses of RO7821657 in multiple participant cohorts.
Drug: EXPERIMENTAL: Part 2B: Dose Expansion/Optimization
Drug: Participants with non-squamous NSCLC will receive RO7821657 at dosing regimen selected based on data from Part 2A.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • * 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.
Exclusion criteria
  • 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.
  • a) 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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Will Be Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer