Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
Phase 1b is AMG 820 dose determining and aimed at assessing the safety and tolerability of the selected starting dose of AMG 820 in combination with pembrolizumab. Phase 2 of the study will further evaluate safety and tolerability and additionally test whether AMG 820 can enhance the anti-tumor activity observed historically with pembrolizumab alone and/or overcome lack of response to pembrolizumab monotherapy in subjects with select solid tumors.
Conditions
This trial is treating people with Pancreatic, Colorectal, Non Small Cell Lung Cancer
Eligibility
Inclusion
- Pathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment.
- Measurable disease per RECIST 1.1 guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests.
- Availability of recent tumor tissue within 3 months prior to enrollment, when feasible.
Exclusion
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- History of other malignancy with the past 2 years with some exceptions
- Evidence of active non-infectious pneumonitis/interstitial lung disease
- Evidence of other active autoimmune disease that has required prolonged systemic treatment in past 2 years.
- Evidence of clinically significant immunosuppression such as organ or stem cell transplantation, any severe congenital or acquired cellular and/or humoral immune deficiency, concurrent opportunistic infection.
- Receiving systemic immunostimulatory agents within 6 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment (except ant PD-1/PD-L1 treatment if recruited into Group 4a or 4b).
- Evidence of active infection within 2 weeks prior to first dose of study treatment.
- Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment
- Currently participating or has participated in a study (treatment period only) of an investigational agent or used an investigational device within 28 days of enrollment
- Received live vaccine within 28 days prior to enrollment
- Adverse event due to cancer therapy administered more than 28 days prior to enrollment that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better.
- Positive for human immunodeficiency virus (HIV), Hepatitis B or C
- Women planning to become pregnant or who are lactating/breastfeeding while on study through 4 months after receiving the last dose of study drug.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AMGEN
Scientific Title
A Phase1b/2 Study Assessing Safety and Anti-tumor Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumors
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