> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-ngm831-as-monotherapy-and-in-combination-with-7970d447-b35f-4677-ba91-603376ef237e > Record changed: 2026-11-04 # Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors NCT05215574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) Participants 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) Lead sponsor NGM Biopharmaceuticals, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) Start date 2022-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Title and summary **Summary** Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Short title** Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Official title** A Phase 1 Dose Escalation/Dose Finding Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Dates **Completion date** 2026-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **First posted** 2022-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Registry last updated** 2024-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Primary completion date** 2025-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Start date** 2022-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Size and sites **Participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Planned participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Lead sponsor** NGM Biopharmaceuticals, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Identifiers **Registry ID** NCT05215574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **ClinicalTrials.gov ID** NCT05215574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Outcomes ### Primary outcomes 1. Number of Patients with Dose-limiting Toxicities Timeframe: Baseline up to 21 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 21 days after the first dose of study treatment. 2. Incidence of Adverse Events Timeframe: Baseline up to Approximately 24 months Number of patients with treatment-emergent adverse events (AEs) 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. ### Secondary outcomes 1. Maximum Observed Serum Concentration (Cmax) of NGM831 Timeframe: Baseline up to approximately 9 weeks Cmax is defined as the observed maximum serum concentration post drug administration. Will be measured for Cycle 1 and Cycle 3. 2. Time to Maximum Observed Serum Concentration (Tmax) of NGM831 Timeframe: Baseline up to approximately 9 weeks Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration. Will be measured for Cycle 1 and Cycle 3. 3. Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831 Timeframe: Baseline up to approximately 9 weeks AUC is defined as area under the concentration time curve of the dosing interval post drug administration. Will be calculated for Cycle 1 and Cycle 3. 4. Maximum Observed Serum Concentration (Cmax) of NGM438 Timeframe: Baseline up to approximately 9 weeks Cmax is defined as the observed maximum serum concentration post drug administration.Will be measured for Cycle 1 and Cycle 3. 5. Time to Maximum Observed Serum Concentration (Tmax) of NGM438. Timeframe: Baseline up to approximately 9 weeks Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration. Will be measured for Cycle 1 and Cycle 3. 6. Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438 Timeframe: Baseline up to approximately 9 weeks AUC is defined as area under the concentration time curve of the dosing interval post drug administration. Will be calculated for Cycle 1 and Cycle 3. 7. Anti-drug Antibodies (ADA) Against NGM831 Timeframe: Baseline up to approximately 24 months Incidence and titers of anti-drug antibodies (ADA) against NGM831\. Will be measured on Day 1 of each cycle. 8. Anti-drug Antibodies (ADA) Against NGM438 Timeframe: Baseline up to approximately 24 months Incidence and titers of anti-drug antibodies (ADA) against NGM438\. Will be measured on Day 1 of each cycle. 9. Neutralizing antibodies (nAb) against NGM831 Timeframe: Baseline up to approximately 24 months Incidence and titers of neutralizing antibodies (nAb) against NGM831\. Will be measured on Day 1 of each cycle. 10. Neutralizing antibodies (nAb) against NGM438 Timeframe: Baseline up to approximately 24 months Incidence and titers of neutralizing antibodies (nAb) against NGM438\. Will be measured on Day 1 of each cycle. 11. Number of Patients with Objective Responses Timeframe: 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) divided by the total number of evaluable patients per RECIST v1.1. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy. - 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 ILT3. - Prior treatment targeting LAIR1. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Sites - NGM Clinical Study SiteGilbert, United States - NGM Clinical Study SiteLos Angeles, United States - NGM Clinical Study SiteSarasota, United States - NGM Clinical Study SiteTampa, United States - NGM Clinical Study SiteGrand Rapids, United States - NGM Clinical Study SiteNew York, United States - NGM Clinical Study SiteOklahoma City, United States - NGM Clinical Study SiteAustin, United States - NGM Clinical Study SiteHouston, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## References ### Other registry identifiers - KEYNOTE-E13 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05215574) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [NGM Biopharmaceuticals, Inc](https://trialight.com/data/company/ngm-biopharmaceuticals-inc-310377e7-3cb3-4d1b-b568-c93fad7d1af2.md) ### Conditions (21) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) - [Cholangiocarcinoma](https://trialight.com/data/condition/cholangiocarcinoma-3777afe4-5189-5eb1-82f8-0c3446cb902f.md) - [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endocervical carcinoma](https://trialight.com/data/condition/endocervical-carcinoma-9b34304c-f01c-53a9-bde7-570df778ad4b.md) - [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Malignant pancreatic neoplasm](https://trialight.com/data/condition/malignant-pancreatic-neoplasm-5dd0b53e-5962-50ea-a2e5-cf2444bd0485.md) Primary condition - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) - [Mesothelioma](https://trialight.com/data/condition/mesothelioma-49ad8bc3-59bf-506b-aa1a-b31c5d0f0e9d.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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