NGM707 for Squamous Cell Carcinoma of the Head and Neck

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Squamous Cell Carcinoma of the Head and Neck+20 MoreNGM707 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, NGM707, as a possible treatment for advanced solid tumors. It will be tested alone and in combination with another cancer drug, pembrolizumab.

Eligible Conditions
  • Squamous Cell Carcinoma of the Head and Neck
  • Stomach Cancer
  • Breast Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Bile Duct Cancer
  • Glioblastoma
  • Mesothelioma
  • Kidney Cancer
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Cervical Cancer
  • Colorectal Cancer
  • Esophageal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

8 Primary · 5 Secondary · Reporting Duration: Up to approximately 48 months

Day 28
Number of Patients with Dose-limiting Toxicities
Month 24
Incidence of Adverse Events
Number of Patients with Clinically Significant Laboratory Abnormalities
Month 24
Anti-drug Antibodies (ADA) Against NGM707
Area Under the Curve (AUC) of Plasma NGM707
Duration of Response for Patients in Expansion Cohorts
Neutralizing Antibodies (NAb) Against NGM707
Number of Patients in Expansion Cohorts with Objective Responses
Observed Plasma Concentration of NGM707 (Including Cmax)
Plasma Half-life (t1/2) of NGM707
Progression-free Survival for Patients in Expansion Cohorts
Month 48
Overall Survival for Patients in Combination Dose Expansion Cohorts
Overall Survival for Patients in Expansion Cohorts of Part 2b

Trial Safety

Safety Progress

1 of 3

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Trial Design

7 Treatment Groups

NGM707 Combination Dose Expansion Arm F
1 of 7
NGM707 Monotherapy Dose Expansion Arm B
1 of 7
NGM707 Combination Dose Expansion Arm E
1 of 7
NGM707 Monotherapy Dose Expansion Arm A
1 of 7
NGM707 Monotherapy Dose Escalation
1 of 7
NGM707 Monotherapy Dose Expansion Arm C
1 of 7
NGM707 Combination Dose Finding with pembrolizumab
1 of 7

Experimental Treatment

179 Total Participants · 7 Treatment Groups

Primary Treatment: NGM707 · No Placebo Group · Phase 1 & 2

NGM707 Combination Dose Expansion Arm F
Drug
Experimental Group · 1 Intervention: NGM707 plus pembrolizumab · Intervention Types: Drug
NGM707 Monotherapy Dose Expansion Arm B
Drug
Experimental Group · 1 Intervention: NGM707 · Intervention Types: Drug
NGM707 Combination Dose Expansion Arm E
Drug
Experimental Group · 1 Intervention: NGM707 plus pembrolizumab · Intervention Types: Drug
NGM707 Monotherapy Dose Expansion Arm A
Drug
Experimental Group · 1 Intervention: NGM707 · Intervention Types: Drug
NGM707 Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: NGM707 · Intervention Types: Drug
NGM707 Monotherapy Dose Expansion Arm C
Drug
Experimental Group · 1 Intervention: NGM707 · Intervention Types: Drug
NGM707 Combination Dose Finding with pembrolizumab
Drug
Experimental Group · 1 Intervention: NGM707 plus pembrolizumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 48 months

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor
23 Previous Clinical Trials
1,991 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,683 Previous Clinical Trials
4,957,929 Total Patients Enrolled
8 Trials studying Squamous Cell Carcinoma of the Head and Neck
553 Patients Enrolled for Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient refused standard of care treatments that they felt didn't offer much clinical benefit.
A tumor that is advanced or has spread to other parts of the body is considered to be locally advanced or metastatic.
The patient must have adequate bone marrow, kidney, and liver function in order to be a candidate for the treatment.
A performance status of 0 or 1 means that the person is no longer able to carry out normal activities.
Any side effects from previous treatments will be graded as they were before the treatment began, except for any side effects that might be a safety risk.