Microsatellite Stable Relapsed or Refractory Colorectal CancerPhase 2NCT03258398
A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer
A Phase 2 study testing eFT508 and Avelumab in people with Microsatellite Stable Relapsed or Refractory Colorectal Cancer, run by Effector Therapeutics at 7 sites in United States.
Trial 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 escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microsatellite Stable Relapsed or Refractory Colorectal Cancer
- What is being tested?
- eFT508 and Avelumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Sep 2017to 13 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
MD Anderson Cancer Center
Houston, Texas, 77030
Kansas City Research Institute
Kansas City, Missouri, 64131
Tennessee Oncology
Nashville, Tennessee, 37203
Mayo Clinic
Rochester, Minnesota, 55905
Florida Cancer Specialists
Sarasota, Florida, 34232
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: A Phase 2, Open-Label, Randomized, Non-Comparative Study With Preliminary Dose Finding to Evaluate eFT508 Monotherapy or eFT508 in Combination With Avelumab in Subjects With Microsatellite Stable Relapsed or Refractory Colorectal Cancer
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 escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics.
- Being tested
- eFT508, Avelumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eFT508Drug
eFT508 will be taken orally (PO) twice a day (bid).
AvelumabDrug
Avelumab 10 mg/kg will be administered intravenously (IV) on Day 1 and once every 2 weeks (q2wk) thereafter
| Study group | Role | What they receive |
|---|---|---|
| Part 1: eFT508 plus avelumab dose finding Arm | Experimental | subjects will receive eFT508 in combination with a fixed dose of avelumab Receives: Drug: eFT508; Drug: Avelumab |
| Part 2: eFT508 plus avelumab | Experimental | subjects will receive eFT508 in combination with a fixed dose of avelumab Receives: Drug: eFT508; Drug: Avelumab |
| Part 2: eFT508 alone | Experimental | subjects will receive eFT508 alone Receives: Drug: eFT508 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Proportion of subjects with a dose limiting toxicity (DLT) during the first treatment cycle
Measured: 28 days
Part 2: Overall Response Rate
the proportion of subjects whose best overall response is a complete or partial response
Measured: 8-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start18 Sep 2017
- Primary completion26 Mar 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsatellite Stable Relapsed or Refractory Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In Part 1, subjects will receive eFT508 in combination with a fixed dose of avelumab. Once the recommended dose of eFT508 in combination with avelumab is determined in Part 1, enrollment in Part 2 will begin. Subjects will be randomized in approximately a 2:1 ratio to receive eFT508 in combination with avelumab or eFT508 monotherapy.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effector Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany, Pfizer
- Responsible party
- Sponsor
- Investigators
- Jeremy Barton, MD, Study director, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258398
- Sponsor's protocol ID
- eFT508-0006
- Status last verified
- Jul 2019
- First submitted
- 21 Aug 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Randomized, Non-Comparative Study With Preliminary Dose Finding to Evaluate eFT508 Monotherapy or eFT508 in Combination With Avelumab in Subjects With Microsatellite Stable Relapsed or Refractory Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03258398
- Acronym / sponsor ID
- eFT508-0006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Effector TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany, Pfizer
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In Part 1, subjects will receive eFT508 in combination with a fixed dose of avelumab. Once the recommended dose of eFT508 in combination with avelumab is determined in Part 1, enrollment in Part 2 will begin. Subjects will be randomized in approximately a 2:1 ratio to receive eFT508 in combination with avelumab or eFT508 monotherapy.
| Arm | Type | Receives |
|---|---|---|
| Part 1: eFT508 plus avelumab dose finding Arm | Experimental | Drug: eFT508, Drug: Avelumabsubjects will receive eFT508 in combination with a fixed dose of avelumab |
| Part 2: eFT508 plus avelumab | Experimental | Drug: eFT508, Drug: Avelumabsubjects will receive eFT508 in combination with a fixed dose of avelumab |
| Part 2: eFT508 alone | Experimental | Drug: eFT508subjects will receive eFT508 alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eFT508eFT508 will be taken orally (PO) twice a day (bid). | Drug | Part 1: eFT508 plus avelumab dose finding Arm, Part 2: eFT508 alone, Part 2: eFT508 plus avelumab |
| AvelumabAvelumab 10 mg/kg will be administered intravenously (IV) on Day 1 and once every 2 weeks (q2wk) thereafter | Drug | Part 1: eFT508 plus avelumab dose finding Arm, Part 2: eFT508 plus avelumab |
Primary outcome
Part 1: Proportion of subjects with a dose limiting toxicity (DLT) during the first treatment cycle
Time frame: 28 days
Part 2: Overall Response Rate
Time frame: 8-16 weeks
the proportion of subjects whose best overall response is a complete or partial response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Barton, MD study director
CMO
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eFT508 and Avelumab in people with Microsatellite Stable Relapsed or Refractory Colorectal Cancer, run by Effector Therapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Proportion of subjects with a dose limiting toxicity (DLT) during the first treatment cycle (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.