Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Melanoma; Bladder Cancer; Head Neck Squamous Cell Carcinoma; Esophageal Cancer; Gastric Cancer; Non-small Cell Lung Cancer; Metastatic Castration-resistant Prostate Cancer; Ovarian Cancer; Prostate Cancer; Colorectal Cancer; Pancreatic Cancer

Treatments: Biological: NGM120 100mg Q3W; Biological: NGM120 100mg with Gemcitabine and Abraxane; Biological: NGM120 100mg; Biological: NGM120 30mg; Biological: NGM120 30mg with Gemcitabine and Abraxane; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04068896

18-0402

Details and patient eligibility

About

Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).

Full description

The aim of the study is to evaluate the safety and tolerability of NGM120 monotherapy in subjects with select advanced solid tumors (Part 1), NGM120 in combination with gemcitabine and Abraxane for the management of metastatic pancreatic cancer (Part 2), and NGM120 in metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed under 1 or more lines of ADT (Part 3), for up to 24 months of treatment.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Part 1 and 2):

1. Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line.
2. Have not received any approved chemotherapy, except in the adjuvant setting.
3. Life expectancy of at least 12 weeks
4. Male subjects must agree to use contraception as per protocol during the treatment period and for at least 90 days after the last study treatment administration and refrain from donating sperm during this period.
5. Provision of an archival tumor sample (within 5 years). If an archival sample is unavailable, a fresh biopsy can be obtained during Screening. If archival tissue or biopsy sample is unavailable, the subject is ineligible.

Inclusion Criteria (Part 3 Prostate Cancer):

1. Metastatic, castrate resistance, histologically confirmed prostate cancer; continuous medical castration for ≥8 weeks prior to screening.
2. Effective castration with serum testosterone levels <0.5 ng/mL (50 ng/dL; 1.7 nmol/L).
3. Have serum GDF15 levels ≥1300 pg/mL.
4. Have experienced PSA progression under 1 or more lines of ADT in the absence or presence of radiographic and/or clinical progression, who decline or are not eligible to receive chemotherapy.
5. Have had PSA doubling time of >3 months.

Exclusion Criteria (All parts):

1. Subject was using immunosuppressive medications within 14 days before Screening with the exception of topical (intranasal, inhaled, and local injection), systemic (prednisone equivalent 10 mg/day or less), or as needed for hypersensitivity reactions such as computed tomography (CT) scan premedication.
2. Subject has active infections or other serious underlying significant medical illness, abnormal and clinically significant laboratory findings or psychiatric illness/social situation.
3. Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants, cochlear implants, or other electronic medical equipment.
4. Subject has documented immunodeficiency or organ transplant.
5. Subject has an untreated central nervous system disease, leptomeningeal disease or cord compression.
6. Subject has a history, or presence, of significant cardiovascular diseases; including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months before randomization, congestive heart failure > New York Heart Association Class II, severe peripheral vascular disease, corrected QT (QTc) prolongation >470 msec, clinically significant pericardial effusion.
7. Subject has a history or presence of documented inflammatory bowel disease.
8. Subject is known to be positive for human immunodeficiency virus (HIV) infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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89 participants in 6 patient groups, including a placebo group

Part 1 NGM120 30mg

Experimental group

Description:

NGM120 30mg Subcutaneous Injection

Treatment:

Biological: NGM120 30mg

Part 1 NGM120 100mg

Experimental group

Description:

NGM120 100mg Subcutaneous Injection

Treatment:

Biological: NGM120 100mg

Part 2 NGM120 30mg

Experimental group

Description:

NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).

Treatment:

Biological: NGM120 30mg with Gemcitabine and Abraxane

Part 2 NGM120 100mg

Experimental group

Description:

NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).

Treatment:

Biological: NGM120 100mg with Gemcitabine and Abraxane

Part 3 NGM120 100mg Q3W

Experimental group

Description:

NGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks

Treatment:

Biological: NGM120 100mg Q3W

Part 2 Placebo

Placebo Comparator group

Description:

Placebo together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).

Treatment:

Other: Placebo