Trial Summary
What is the purpose of this trial?First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Eligibility Criteria
This trial is for adults with certain solid tumors, including metastatic melanoma, platinum-resistant ovarian cancer, and pancreatic cancer. Participants must have tried some standard treatments without success and can't have had more than three prior systemic therapies. Pregnant women or those who've had severe reactions to similar drugs are excluded.Inclusion Criteria
My pancreatic cancer has worsened despite treatment with FOLFIRINOX or a gemcitabine-based regimen.
My head or neck cancer worsened despite treatment with an anti-PD1/L1 drug.
My breast cancer is triple negative and has spread.
My melanoma cannot be removed by surgery and has spread.
My breast cancer is triple negative and has been tested for PD-L1.
My pancreatic cancer is advanced, cannot be surgically removed, or has come back after surgery.
My cancer is a type of skin cancer that has spread from my head or neck.
My ovarian cancer did not respond to initial platinum-based chemotherapy.
I have a confirmed diagnosis of advanced ovarian, fallopian tube, or peritoneal cancer.
My melanoma got worse despite treatment with an anti-PD1/L1 drug.
I have had 3 or fewer treatments for advanced melanoma.
Exclusion Criteria
I stopped a cancer immunotherapy due to a severe side effect.
Participant Groups
The study tests ENB003 combined with Pembrolizumab on patients with solid tumors. It has two parts: Part A finds the safest dose (RP2D) through a '3+3' method; Part B expands the trial using this dose on specific cancers, including an exploratory group of sarcoma patients.
7Treatment groups
Experimental Treatment
Group I: ENB003 RP2D from dose escalation + PembrolizumabExperimental Treatment2 Interventions
The recommended phase 2 dose (RP2D) of ENB003 will be selected from the dose escalation portion of the study and administered in combination with a fixed dose of pembrolizumab (200mg)
Group II: ENB003 750 ug + PembrolizumabExperimental Treatment2 Interventions
750 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Group III: ENB003 500 ug + PembrolizumabExperimental Treatment2 Interventions
500 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Group IV: ENB003 300 ug + PembrolizumabExperimental Treatment2 Interventions
300 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Group V: ENB003 2000 ug + PembrolizumabExperimental Treatment2 Interventions
2000 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg). In this treatment arm, ENB003 will be administered during each 21 day cycle, as opposed to every other cycle in early arms
Group VI: ENB003 150 ug + PembrolizumabExperimental Treatment2 Interventions
150 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Group VII: ENB003 1000 ug + PembrolizumabExperimental Treatment2 Interventions
1000 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Cedars Sinai-The Angeles ClinicLos Angeles, CA
MD Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
ENB Therapeutics, IncLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor