Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04913337 |
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Recruitment Status :
Recruiting
First Posted : June 4, 2021
Last Update Posted : February 10, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Drug: NGM707 Drug: NGM707 plus pembrolizumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 179 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 9, 2021 |
| Estimated Primary Completion Date : | February 2025 |
| Estimated Study Completion Date : | July 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: NGM707 Monotherapy Dose Escalation
Part 1a Single Agent Dose Escalation
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Drug: NGM707
Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. |
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Experimental: NGM707 Combination Dose Finding with pembrolizumab
Part 1b NGM707 plus pembrolizumab
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Drug: NGM707 plus pembrolizumab
Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle. |
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Experimental: NGM707 Monotherapy Dose Expansion Arm A
NGM707 in RCC
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Drug: NGM707
Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. |
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Experimental: NGM707 Monotherapy Dose Expansion Arm B
NGM707 in CRC
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Drug: NGM707
Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. |
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Experimental: NGM707 Monotherapy Dose Expansion Arm C
NGM707 in Ovarian Cancer
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Drug: NGM707
Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. |
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Experimental: NGM707 Combination Dose Expansion Arm E
NGM707 with pembrolizumab in NSCLC
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Drug: NGM707 plus pembrolizumab
Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle. |
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Experimental: NGM707 Combination Dose Expansion Arm F
NGM707 with pembrolizumab in SCCHN
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Drug: NGM707 plus pembrolizumab
Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle. |
- Number of Patients with Dose-limiting Toxicities [ Time Frame: Baseline up to 28 Days ]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.
- Incidence of Adverse Events [ Time Frame: Baseline up to Approximately 24 Months ]
Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.
- Number of Patients with Clinically Significant Laboratory Abnormalities [ Time Frame: Baseline up to Approximately 24 Months ]Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.
- Number of Patients in Expansion Cohorts with Objective Responses [ Time Frame: Baseline up to approximately 24 months ]Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
- Duration of Response for Patients in Expansion Cohorts [ Time Frame: Baseline up to approximately 24 months ]Duration of Response is defined as the time from the first documentation of objective response (CR or PR) that is subsequently confirmed per RECIST v1.1, to the time of the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
- Progression-free Survival for Patients in Expansion Cohorts [ Time Frame: Baseline up to approximately 24 months ]Progression-free survival is defined as the time from start of study treatment to the date of first documentation of objective tumor progression on or following study therapy per RECIST v1.1, or to death due to any cause, whichever comes first.
- Overall Survival for Patients in Combination Dose Expansion Cohorts [ Time Frame: Up to approximately 48 months ]Overall survival is defined as the date from start of the study treatment to the date of death due to any cause.
- Observed Plasma Concentration of NGM707 (Including Cmax) [ Time Frame: Baseline up to approximately 24 months ]Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.
- Area Under the Curve (AUC) of Plasma NGM707 [ Time Frame: Baseline up to approximately 24 months ]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. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.
- Plasma Half-life (t1/2) of NGM707 [ Time Frame: Baseline up to approximately 24 months ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.
- Anti-drug Antibodies (ADA) Against NGM707 [ Time Frame: Baseline up to approximately 24 months ]Incidence and titers of anti-drug antibodies (ADA) against NGM707. Will be measured on Day 1 of each cycle.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913337
| Contact: NGM Medical Director | (650) 243-5555 | NGM707@ngmbio.com |
Show 17 study locations
| Responsible Party: | NGM Biopharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT04913337 |
| Other Study ID Numbers: |
707-IO-101 KEYNOTE-D25 ( Other Identifier: Merck Sharp & Dohme Corp ) |
| First Posted: | June 4, 2021 Key Record Dates |
| Last Update Posted: | February 10, 2023 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carcinoma Glioblastoma Mesothelioma Cholangiocarcinoma Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Carcinoma, Squamous Cell |
Adenocarcinoma Astrocytoma Glioma Neoplasms, Neuroepithelial Head and Neck Neoplasms Adenoma Neoplasms, Mesothelial Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |