Description:
Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or
Metastatic Solid Tumor Malignancies
Title
- Brief Title: Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
- Official Title: A Phase 1/2 Dose Escalation/Expansion Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Clinical Trial IDs
- ORG STUDY ID:
707-IO-101
- NCT ID:
NCT04913337
Conditions
- Mesothelioma
- Glioblastoma
- Renal Cell Carcinoma
- Non Small Cell Lung Cancer
- Melanoma
- Pancreatic Ductal Adenocarcinoma
- Gastric Cancer
- Squamous Cell Carcinoma of Head and Neck
- Cholangiocarcinoma
- Breast Cancer
- Ovarian Cancer
- Cervical Cancer
- Endocervical Cancer
- Colorectal Cancer
- Esophageal Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| NGM707 | | NGM707 Monotherapy Dose Escalation |
| NGM707 plus pembrolizumab | | NGM707 Combination Dose Finding with pembrolizumab |
| NGM707 | | NGM707 Monotherapy Dose Expansion Arm A |
| NGM707 | | NGM707 Monotherapy Dose Expansion Arm B |
| NGM707 | | NGM707 Monotherapy Dose Expansion Arm C |
| NGM707 plus pembrolizumab | | NGM707 Combination Dose Expansion Arm E |
| NGM707 plus pembrolizumab | | NGM707 Combination Dose Expansion Arm F |
Purpose
Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or
Metastatic Solid Tumor Malignancies
Trial Arms
| Name | Type | Description | Interventions |
|---|
| NGM707 Monotherapy Dose Escalation | Experimental | Part 1a Single Agent Dose Escalation | |
| NGM707 Combination Dose Finding with pembrolizumab | Experimental | Part 1b NGM707 plus pembrolizumab | - NGM707 plus pembrolizumab
|
| NGM707 Monotherapy Dose Expansion Arm A | Experimental | NGM707 in RCC | |
| NGM707 Monotherapy Dose Expansion Arm B | Experimental | NGM707 in CRC | |
| NGM707 Monotherapy Dose Expansion Arm C | Experimental | NGM707 in Ovarian Cancer | |
| NGM707 Combination Dose Expansion Arm E | Experimental | NGM707 with pembrolizumab in NSCLC | - NGM707 plus pembrolizumab
|
| NGM707 Combination Dose Expansion Arm F | Experimental | NGM707 with pembrolizumab in SCCHN | - NGM707 plus pembrolizumab
|
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically documented locally advanced or metastatic solid tumor
malignancy.
- Progressed or was intolerant to all available therapies known to confer clinical
benefit appropriate for their tumor type, and for which the patient was eligible and
willing to receive, or refused SOC treatments that are perceived to have marginal
clinical benefit.
- Adequate bone marrow, kidney and liver function.
- Performance status of 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
except for AEs not constituting a safety risk by Investigator judgement.
Exclusion Criteria:
- Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Patients with Dose-limiting Toxicities |
| Time Frame: | Baseline up to 28 Days |
| Safety Issue: | |
| Description: | A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0, and is considered by the investigator to be clinically relevant and attributed to the study treatment during the first 28 days after the first dose of study treatment. |
Secondary Outcome Measures
| Measure: | Observed Plasma Concentration of NGM707 (Including Cmax) |
| Time Frame: | Baseline up to approximately 24 months |
| Safety Issue: | |
| Description: | NGM707 will be measured at the end of infusion on Cycle 1 Day 1 and on days 2, 4, 8, and 15 of Cycle 1; pre-dose and end of infusion on Day 1 of Cycle 2, and every cycle thereafter. |
| Measure: | Area Under the Curve (AUC) of Plasma NGM707 |
| Time Frame: | Baseline up to approximately 24 months |
| Safety Issue: | |
| Description: | Area under the curve from time zero extrapolated to the last quantifiable dose of NGM707. Time zero extrapolated to the last quantifiable time point prior to the next dose. NGM707 will be measured at the end of infusion on Cycle 1 Day 1 and on days 2, 4, 8, and 15 of Cycle 1; pre-dose and end of infusion on Day 1 of Cycle 2, and every cycle thereafter. |
| Measure: | Plasma Half-life (t1/2) of NGM707 |
| Time Frame: | Baseline up to approximately 24 months |
| Safety Issue: | |
| Description: | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. NGM707 will be measured at the end of infusion on Cycle 1 Day 1 and on days 2, 4, 8, and 15 of Cycle 1; pre-dose and end of infusion on Day 1 of Cycle 2, and every cycle thereafter. |
| Measure: | Anti-drug Antibodies (ADA) Against NGM707 |
| Time Frame: | Baseline up to approximately 24 months |
| Safety Issue: | |
| Description: | Incidence and titers of anti-drug antibodies (ADA) against NGM707. NGM707 will be measured pre-dose on Day 1 of Cycle 1, and every cycle thereafter. |
| Measure: | Neutralizing Antibodies (NAb) Against NGM707 |
| Time Frame: | Baseline up to approximately 24 months |
| Safety Issue: | |
| Description: | Incidence and titers of neutralizing antibodies (NAb) against NGM707. NGM707 will be measured pre-dose on Day 1 of Cycle 1, and every cycle thereafter. |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | NGM Biopharmaceuticals, Inc |
Last Updated
June 14, 2021
