Lung Cancer Clinical Trial

A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors

Summary

This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent RO7121661, an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of RO7121661. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of RO7121661 from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

General Inclusion Criteria:

Part A: Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient
Eastern Cooperative Oncology Group Performance Status 0-1
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Fresh biopsies may be required
Negative HIV, hepatitis B, or hepatitis C test result
Women of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocol

Additional Specific Inclusion Criteria for Participants with Melanoma:

Histologically confirmed, unresectable stage III or stage IV melanoma
Previously treated with approved anti-programmed death-ligand 1 (PD-L1)/anti-programmed death-1 (PD-1) agents with or without approved anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapy and up to one additional treatment regimen

Additional Specific Inclusion Criteria for Participants with Non-small Cell Lung Cancer (NSCLC) who Previously Received Treatment for Metastatic Disease:

Histologically confirmed advanced NSCLC
Previously treated with approved PD-L1/PD-1 inhibitors and platinum-based chemotherapy
Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling to the study
Participants must have experienced initial clinical benefit (stable disease or better) from most recent checkpoint inhibitor (CPI) therapy
Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening

Additional Specific Inclusion Criteria for Participants with Non-small Cell Lung Cancer (NSCLC) who Previously Did Not Receive Treatment for Metastatic Disease:

Histologically confirmed advanced NSCLC
Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening

Additional Specific Inclusion Criteria for Participants with Small Cell Lung Cancer (SCLC):

Histologically confirmed SCLC
Participants may have had prior chemotherapy, radiation therapy, or declined approved therapies for SCLC

Additional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma (ESCC):

Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
Patients who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling to the study

Exclusion Criteria:

General Exclusion Criteria:

Pregnancy, lactation, or breastfeeding
Known hypersensitivity to any of the components of RO7121661
Active or untreated central nervous system (CNS) metastases
An active second malignancy
Evidence of concomitant diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection
Treatment with oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
Active or history of autoimmune disease or immune deficiency
Prior treatment with adoptive cell therapies, such as CAR-T therapies
Concurrent therapy with any other investigational drug <28 days or 5 half-lives of the drug, whichever is shorter, prior to first RO7247669 administration
Regular immunosuppressive therapy
Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy
Prior treatment with a T-cell immunoglobulin and mucin domain-3 (TIM-3) inhibitor

Additional Specific Exclusion Criteria for Participants with NSCLC who Previously Received Treatment for Metastatic Disease:

- Patients with the following mutations, rearrangements, translocations are not eligible: epidermal growth factor receptor (EGFR); anaplastic lymphoma kinase (ALK); ROS proto-oncogene 1 (ROS1), BRAFV600E, and neurotrophic receptor tyrosine kinase (NTRK)

Additional Specific Exclusion Criteria for Participants with NSCLC who Did Not Previously Receive Treatment for Metastatic Disease:

Prior therapy for metastatic disease
Adjuvant anti-PD-1 or anti-PD-L1 therapy

Additional Specific Exclusion Criteria for Participants with Small-Cell Lung Cancer (SCLC):

- Prior therapy with any immune CPIs (such as anti-PD-L1/PD-1, CTLA-4)

Additional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma (ESCC):

- Prior therapy with any immunomodulatory agents

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT03708328

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 17 Locations for this study

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Columbia Univ Med Ctr
New York New York, 10032, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Herlev Hospital; Afdeling for Kræftbehandling
Herlev , 2730, Denmark
Rigshospitalet; Onkologisk Klinik
København Ø , 2100, Denmark
Institut Bergonie; Oncologie
Bordeaux , 33076, France
Centre Leon Berard; Service Oncologie Medicale
Lyon , 69008, France
CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)
Marseille , 13005, France
ICO Rene Gauducheau; CEC
St Herblain , 44805, France
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Auckland City Hospital; Clinical Oncology
Auckland , 1023, New Zealand
Clinica Universitaria de Navarra; Servicio de oncología
Pamplona Navarra, 31008, Spain
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona , 08035, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT03708328

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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