NCT04266912

Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors

Active, enrolled Phase 1, PHASE2 Results posted Last updated 25 November 2025

What this trial tests

Phase 1, PHASE2 trial testing Avelumab in Metastatic Malignant Solid Neoplasm in 23 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 March 2020

Primary endpoint
13 November 2024

31 December 2025

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	17 March 2020
Primary completion	13 November 2024
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Avelumab (avelumab) — full drug profile →
• Berzosertib — full drug profile →

Conditions studied

• Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →
• Refractory Malignant Solid Neoplasm — all drugs for Refractory Malignant Solid Neoplasm →
• Unresectable Malignant Solid Neoplasm — all drugs for Unresectable Malignant Solid Neoplasm →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Metastatic Malignant Solid Neoplasm or Refractory Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine the Recommended Phase 2 Dose (RP2D). Primary · The DLT monitoring time frame was the first 28-days of study participation (Cycle 1).

A DLT was evaluated according to the NCI CTCAE 5.0 \& defined as: grade 4 neutropenia lasting greater than 7 days or febrile neutropenia, grade 3 thrombocytopenia with bleeding or grade 4 thrombocytopenia lasting greater than 7 days, any treatment related adverse event that in the opinion of the safety monitoring committee exposes participants to unacceptable risk, a delay of more than 4 weeks before receiving the next scheduled study drug due to persisting toxicities attributable to study drugs, grade 3 nausea, vomiting or diarrhea lasting greater than 72 hours with optimal care, grade 3 fati

DLT

Group	Value	95% CI
Escalation Dose Level 1	1
Escalation Dose Level 2	0
Expansion Dose Level 2	0

Not DLT

Group	Value	95% CI
Escalation Dose Level 1	5
Escalation Dose Level 2	6
Expansion Dose Level 2	10

Not evaluable for DLT

Group	Value	95% CI
Escalation Dose Level 1	1
Escalation Dose Level 2	0
Expansion Dose Level 2	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Escalation Dose Level 1

Serious: 2/7 (29%)

Deaths: 6/7

Escalation Dose Level 2

Serious: 2/6 (33%)

Deaths: 4/6

Expansion Dose Level 1

Serious: 0

Deaths: 0

Expansion Dose Level 2

Serious: 4/10 (40%)

Deaths: 7/10

Serious adverse events (12 terms)

Reaction	System	Escalation Dose Level 1	Escalation Dose Level 2	Expansion Dose Level 1	Expansion Dose Level 2
Diarrhea	Gastrointestinal disorders	—	—	—	—
Lung Infection	Infections and infestations	—	—	—	—
Disease Progression	General disorders	—	—	—	—
Small Intestinal obstruction	Infections and infestations	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Tumor pain	General disorders	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Thromboembolic event	Vascular disorders	—	—	—	—

Other adverse events (65 terms — click to expand)

Reaction	System	Escalation Dose Level 1	Escalation Dose Level 2	Expansion Dose Level 1	Expansion Dose Level 2
platelet count decreased	Investigations	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Creatinine increased	Investigations	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Fever	General disorders	—	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—
Chills	General disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Hematuria	Renal and urinary disorders	—	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—
Pain	Metabolism and nutrition disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
serum amylase increased	Investigations	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Bloating	Gastrointestinal disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—
Eye disorders	General disorders	—	—	—	—
Flank pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Flushing	Vascular disorders	—	—	—	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Follicular Lymphoma	Blood and lymphatic system disorders	—	—	—	—
Gait Disturbance	General disorders	—	—	—	—
Hiccups	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hypercalcemia	Metabolism and nutrition disorders	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—

Most-reported serious reactions: Diarrhea, Lung Infection, Disease Progression, Small Intestinal obstruction, Abdominal pain, Tumor pain, Aspartate aminotransferase increased, Alanine aminotransferase increased.

Data from ClinicalTrials.gov NCT04266912 adverse events section.

Sponsor's own description

This phase I/II trial studies the side effects and best dose of avelumab with M6620 in treating patients with deoxyribonucleic acid (DNA) damage repair (DDR) deficient solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). DDR deficiency refers to a decrease in the ability of cells to respond to damaged DNA and to repair the damage, which can be caused by genetic mutations. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving avelumab together with M6620 may help to control DDR deficient metastatic or unresectable solid tumors.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.