Status:
COMPLETED
A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer
Lead Sponsor:
Effector Therapeutics
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Pfizer
Conditions:
Microsatellite Stable Relapsed or Refractory Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the safety and tolerability of escal...
Eligibility Criteria
Inclusion
- ECOG performance status of 0, 1, or 2
- Pathologically documented diagnosis of colorectal adenocarcinoma.
- Progressed on or intolerant of at least 2 prior cancer therapy regimens administered for metastatic disease.
- Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥3 weeks before the start of study therapy.
- Part 2 only: Presence of radiographically measurable disease (defined as the presence of ≥1 lesion that measures ≥10 mm \[≥15 mm for lymph nodes\]). Measurable disease that was previously radiated is only permitted if progressing.
- Agrees to undergo a pretreatment and a post-treatment biopsy.
- Microsatellite stable disease determined by IHC and/or polymerase chain reaction (PCR).
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
- Normal coagulation profile
- Negative antiviral serology
- Female subjects of childbearing potential must not be pregnant or breastfeeding
- Willingness to use protocol-recommended methods of contraception or to abstain from heterosexual intercourse from start of therapy until at lest 30 days after the last dose of study therapy
- Life expectancy of ≥3 months.
Exclusion
- History of another malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical or breast carcinoma; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ≥2 years.
- Known symptomatic brain metastases requiring ≥10 mg/day of prednisolone (or its equivalent).
- Significant cardiovascular disease.
- Significant screening ECG abnormalities.
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- Known history of colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis.
- Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis.
- Evidence of an ongoing systemic bacterial, fungal, or viral infection.
- Any condition that may impact the subject's ability to swallow oral medications.
- Major surgery within 4 weeks before the start of study therapy.
- Prior solid organ or bone marrow progenitor cell transplantation.
- Prior therapy with any known inhibitor of MNK-1 or MNK-2.
- Prior therapy with any of the following: PD-1, PD-L1, CTLA4 antibody, or any other drug targeting T cell checkpoint pathways.
- Prior high dose chemotherapy requiring stem cell rescue.
- Intolerance to or prior severe (≥Grade 3) allergic or anaphylactic reaction to infused antibodies or infused therapeutic proteins.
- Vaccination within 4 weeks of the first dose of avelumab and while on study.
- Ongoing immunosuppressive therapy.
- Use of a strong inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to the start of study therapy or expected requirement for use of a strong CYP3A4 inhibitor or inducer during study therapy.
- Previously received investigational product in a clinical trial within 30 days or within 5 elimination half lives (whichever is longer) prior to the start of study therapy, or is planning to take part in another clinical trial while participating in this study.
- Has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2019
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03258398
Start Date
September 18 2017
End Date
May 13 2019
Last Update
July 18 2019
Active Locations (7)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
4
Mayo Clinic
Rochester, Minnesota, United States, 55905