A Phase 1 interventional study of AMG 436 in Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR), sponsored by Amgen. Recruiting at 27 sites in 10 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
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Among 31 studies in Neoplasm Metastasis by Amgen — 1 open to participants now, 1 under way, none of them phase 3. Neoplasm Metastasis · Amgen.
Among the 31 studies in Neoplasm Metastasis by Amgen, this one is the 3rd largest by planned enrollment of the 27 interventional ones that give a count, is the only one that started in 2026, is one of 8 in phase 1, and was the 31st registered.
4,045 studies on the registry are indexed under Neoplasm Metastasis; 888 are open to participants now.
Browse Neoplasm Metastasis studies →1 of the 31 studies in Neoplasm Metastasis by Amgen is open now, in 10 countries.
By country, each count listing its studies:
Of the 689 Neoplasm Metastasis studies recruiting now, 536 (78%) set no upper age limit and 97 (14%) stop at 75 or younger; 48 take children under 18; 18 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 18 · Phase 3 3
First in 2002; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 464 is above the median of 50 across 3,270 interventional studies indexed under Neoplasm Metastasis.
Median enrollment 134 across the 27 interventional studies, 255 across the 2 observational. Of the 30 that completed or were terminated, 16 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
Amgen is the lead sponsor of 1,047 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 31 studies in Neoplasm Metastasis by Amgen, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AMG 436 monotherapy dose escalation.
Drug: AMG 436
Participants will receive AMG 436 under fasted and fed conditions (United States only).
Drug: AMG 436
AMG 436 + combination dose escalation.
Drug: AMG 436
AMG 436 monotherapy Dose expansion and optimization.
Drug: AMG 436
AMG 436 + chemotherapy combination dose expansions.
Drug: AMG 436
AMG 436 will be administered.
Number of Participants with a Dose Limiting Toxicity (DLT)
Time frame: Up to 21 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 5 years
Maximum Serum Concentration (Cmax) of AMG 436
Time frame: Up to 57 days
Minimum Serum Concentration (Cmin) of AMG 436
Time frame: Up to 57 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 436
Time frame: Up to 57 days
Time to Achieve Cmax (Tmax) of AMG 436
Time frame: Up to 57 days
Part 1B: Cmax of AMG 436 in the Fed and/or Fasted State
Time frame: Up to 24 days
Part 1B: Tmax of AMG 436 in the Fed and/or Fasted State
Time frame: Up to 24 days
Part 1B: AUC Over the Dosing Interval of AMG 436 in the Fed and/or Fasted State
Time frame: Up to 24 days
Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to 5 years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to 5 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to 5 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to 5 years
Overall Survival (OS) per RECIST v1.1
Time frame: Up to 5 years
Change From Baseline in Tumor Phosphorylated Checkpoint Kinase 2 (CHK2) Following AMG 436
Time frame: Baseline up to 5 years
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Data sharing details ↗ · www.amgen.com
Started Apr 2026 (actual). Primary completion is estimated for Jan 2030, 44 months after the start.
Of 286 industry-sponsored phase 1 interventional studies under Neoplasm Metastasis, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 75. This study's planned 44 months is close to that.
Counting every sponsor, half of 496 studies reached it within 54 months; a quarter within 33 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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