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Monoclonal Antibodies

Lomvastomig for Solid Cancers

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Histologically confirmed, unresectable stage III or stage IV melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that targets two proteins, PD-1 and TIM-3. The trial will first test different doses to find the best one, then test it on different types of cancer to see if it is effective.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including various types of lung and esophageal cancers or melanoma, who have tried other treatments without success. Participants should be in good physical condition (ECOG 0-1), may have had a limited number of prior treatments, must not be pregnant or breastfeeding, and agree to use contraception. Those with active infections, autoimmune diseases, CNS metastases, or recent immunotherapy are excluded.Check my eligibility
What is being tested?
The study tests Lomvastomig—a new drug targeting PD-1/TIM-3 pathways—in two parts: first to find the highest dose patients can take without serious side effects (Dose Escalation) and then to see how well it works at that dose in specific tumor types (Expansion).See study design
What are the potential side effects?
Potential side effects include typical immune-related reactions such as inflammation in different organs due to an overactive immune system. There might also be infusion reactions where the body reacts negatively during administration of the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has no standard treatment options left.
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My melanoma cannot be removed by surgery and is in stage III or IV.
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I've been treated with specific immune therapies for my cancer.
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My lung cancer is confirmed and advanced.
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I have been treated with PD-L1/PD-1 inhibitors and platinum-based chemotherapy.
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My last cancer treatment, which boosts my immune system, helped stabilize or improve my condition.
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I may need to provide a new biopsy sample.
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I agree to follow the study's rules for preventing pregnancy or fathering a child.
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My cancer is confirmed as small cell lung cancer.
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I have had only one treatment for my cancer after it spread.
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My tumor has been tested for PD-L1 protein.
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I have had 2 or fewer treatments for my cancer since it spread.
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I have had or declined treatment for small cell lung cancer.
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I am fully active or can carry out light work.
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My main cancer lesion is confirmed as squamous or adenosquamous cell carcinoma of the esophagus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation: Number of Participants with a Dose-Limiting Toxicity (DLT)
Dose Escalation: Number of Participants with at Least One Adverse Event, Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Expansion: Disease Control Rate, Assessed According to RECIST v1.1
+3 more
Secondary outcome measures
Dose Escalation and Expansion: Area Under the Concentration-Time Curve (AUC) of Lomvastomig
Dose Escalation and Expansion: Maximum Concentration (Cmax) of Lomvastomig
Dose Escalation and Expansion: Number of Participants with Anti-Drug Antibodies
+10 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Expansion Part B5: ESCC CohortExperimental Treatment1 Intervention
This cohort will comprise participants with CPI-naïve esophageal squamous cell carcinoma (ESCC). The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation.
Group II: Expansion Part B4: SCLC CohortExperimental Treatment1 Intervention
This cohort will comprise participants with CPI naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to, standard therapy. The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation.
Group III: Expansion Part B3: NSCLC Cohort 2Experimental Treatment1 Intervention
This cohort will comprise participants with PD-L1 high, cancer immunotherapy (CIT) naïve first line NSCLC. The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation.
Group IV: Expansion Part B2: NSCLC Cohort 1Experimental Treatment1 Intervention
This cohort will comprise participants with CPI and platinum experienced, second or third line PD-L1 positive non-small cell lung cancer (NSCLC). The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation.
Group V: Expansion Part B1: Metastatic Melanoma CohortExperimental Treatment1 Intervention
This cohort will comprise participants with checkpoint inhibitor (CPI) experienced, second line and beyond metastatic melanoma. The starting dose of lomvastomig for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.
Group VI: Dose Escalation Part A: Once Every 2 Weeks (Q2W)Experimental Treatment1 Intervention
Lomvastomig will be administered in treatment cycles once every 2 weeks (Q2W). Dose escalation will be carried out according to a modified continual reassessment method (mCRM) with escalation with overdose control (EWOC) design.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,088,998 Total Patients Enrolled
50 Trials studying Melanoma
58,504 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,426 Total Patients Enrolled
51 Trials studying Melanoma
42,919 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is RO7121661 hazardous to human health?

"Limited evidence of RO7121661's efficacy and safety has only been established in Phase 1 trials, thus earning it a score of 1."

Answered by AI

Is this research still recruiting participants?

"It appears that the trial, which was initially presented on October 15th 2018 and most recently updated 10/28/2022, is no longer seeking participants. Nonetheless, 2274 other medical studies are currently enrolling patients as of now."

Answered by AI
~2 spots leftby Apr 2024