Status:
TERMINATED
Study to Investigate DRP-104 in Adults With Advanced Solid Tumors
Lead Sponsor:
Dracen Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumor
Non Small Cell Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmaco-dynamics and preliminary anti-tumor activity of DRP-104 (sirpiglenastat) administered via intravenous ...
Detailed Description
This study will be conducted in 4 Parts: Part 1: Phase 1 single-agent dose escalation of DRP-104 administered via IV infusion (Cohort 1a) or subQ injection (Cohort 1b and 1c) in patients with advance...
Eligibility Criteria
Inclusion
- Diagnosis of advanced or recurrent, histologically or cytologically confirmed, measurable by RECIST 1.1 metastatic or unresectable solid tumor
- Patient must have progressed on, be intolerant of, decline, or be ineligible for, all available standard of care therapies
- Part 2: locally advanced or metastatic NSCLC with KEAP1, NFE2L2 and/or STK11 mutation ; Patients must have received at least a platinum doublet chemotherapy and an anti-PD-(L)1 antibody; Received up to 3 lines of systemic anticancer therapy in the recurrent or metastatic setting
- Part 3 and 4 - DRP-104 + atezolizumab Prior exposure to any checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PDL2, and/or anti-CTLA-4 antibody)
- ECOG performance 0 or 1
- Patient must consent to allow acquisition of existing FFPE tumor tissue; If unavailable, patient must consent to new pre-treatment tumor biopsy
- All SCCHN patient, all NSCLC patients and all patients treated with combination of DRP-104 and atezolizumab will be required to undergo pre-treatment and post-treatment core or excisional biopsies.
- Pre-treatment and post-treatment core or excisional biopsies are optional for all remaining patients
- Adequate baseline organ function as defined by: Absolute neutrophil count ≥ 1.5 × 109/L (1500/µL); Hemoglobin ≥ 9 g/dL (patients that require transfusion or growth factors need to demonstrate stable hemoglobin of ≥ 9 g/dL over at least a 7-day period after the last transfusion/growth factor injection prior to screening labs to meet eligibility) ; Platelets ≥ 75 × 109/L (75,000/µL); Hepatic Total bilirubin ≤1.5 × upper limit of normal (ULN): PT/INR and PTT ≤1.5 × ULN, unless treated with warfarin; AST(SGOT)/ALT(SGPT) ≤3 × ULN or ≤ 5 × ULN for patients with liver metastases; Creatinine clearance ≥ 60 ml/min/1.73m2 measured or calculated
- Cardiac QTc (Fridericia) \<470 ms
- Women of child-bearing potential and men who are sexually active must agree to use one highly effective method of contraception
Exclusion
- Patients with primary central nervous system tumors and hepatocellular carcinoma
- Patients with progressive or symptomatic brain metastases or leptomeningeal disease
- Patients who have not recovered to grade 1 or baseline from adverse events (CTCAE v 5.0) related to prior therapy excluding alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ grade 3.
- Lymphopenia ≤ grade 3 is allowed if not related to prior anticancer therapy. If related to prior anticancer therapy, lymphopenia must resolve to ≤ grade 1 or baseline.
- Spinal cord compression not definitively treated with surgery and/or radiation
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage
- Prior glutaminase inhibitor use
- Prior systemic anticancer treatment (i.e., chemotherapy, biologic therapy, monoclonal antibodies, investigational agents) within 21 days or 5 half-lives, whichever is shorter
- Anti-androgen therapies for prostate cancer, such as bicalutamide, within 4 weeks prior to enrollment
- Patients must have recovered from all AEs due to previous therapies to CTCAE v 5.0 grade 1 or baseline, excluding, alopecia, peripheral neuropathy and ototoxicity, which must be at least grade 2 or baseline
- Prior small port palliative radiotherapy within 14 days of start of Cycle 1
- Any major surgery within 21 days from start of Cycle 1
- Secondary malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
- Has a known history of HIV or HBV
- Gastrointestinal (GI) function impairment or GI disease
- Significant, uncontrolled heart disease and/or cardiac repolarization abnormality
- Exclusion specific to only Part 3 and 4 (DRP-104 combined with atezolizumab):
- History of severe allergic, anaphylactic to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells
- Prior anti-PD-1, anti-PD-L1 and/or anti CTLA4- agent, patient must not have had a serious (\> Grade 3) immune-related AE requiring treatment
- History of autoimmune disease except hypothyroidism on thyroid replacement hormone therapy, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- Patients with underlying condition requiring systemic corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications or other systemic immunosuppressant medications may be enrolled in the study after approval by the Medical Monitor
- History of organ transplantation and/or hematopoietic stem cell transplantation
- Evidence or history of active or latent tuberculosis infection
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04471415
Start Date
August 31 2020
End Date
March 28 2023
Last Update
June 12 2023
Active Locations (22)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
UCLA
Los Angeles, California, United States, 90095
3
AdventHealth Medical Group
Kissimmee, Florida, United States, 34747
4
Florida Cancer Specialist
Orlando, Florida, United States, 32827