Status:
WITHDRAWN
Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
Lead Sponsor:
Rain Oncology Inc
Conditions:
Advanced Solid Tumor
CDKN2A
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, single-arm, Phase 1b/2 study designed to evaluate the safety, tolerability, and preliminary efficacy of milademetan in combination with atezolizumab in patients with advanced so...
Detailed Description
Up to 30 patients will be enrolled, 3 to 18 patients in the safety assessment cohort and 12 to 27 patients in the dose expansion cohort.
Eligibility Criteria
Inclusion
- Key
- Has a histologically confirmed, advanced solid tumor that has progressed on prior therapy with an anti-PD-1/L1 inhibitor administered as either monotherapy or in combination with other therapies
- Has documented homozygous CDKN2A loss and Wild-Type TP53
- Confirmation of available tumor tissue collected within 5 years of enrollment
- Measurable tumor lesions per RECIST 1.1
- Estimate life expectancy of at least 6 months
- ECOG PS of 0 or 1
- Resolution of clinically relevant toxic effect of prior anti-cancer therapies Note: AEs from prior therapy must resolve to Grade ≤ 1 per the NCI CTCAE version 5.0, except for peripheral neuropathy, which must resolve to Grade ≤ 2, and alopecia
- Adequate bone marrow, renal and hepatic function
- Key
Exclusion
- Has received prior treatment with any MDM2 inhibitor; prior treatment with atezolizumab is allowed except if the patient discontinued due to toxicity
- Has a history of any Grade 3 or 4 immune-related toxicities to a prior checkpoint inhibitor treatment or history of treatment discontinuation with prior checkpoint inhibitor use due to toxicity
- Endocrinopathies which are stable with appropriate hormonal supplementation consistent with other eligibility parameters
- Dermatologic events which have resolved to Grade ≤ 1 on stable medication, as appropriate, and consistent with other eligibility parameters
- Treatment with systemic immunosuppressive medication, including but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents, within 2 weeks prior to the first dose of study treatment or anticipation of need for systemic immunosuppressive medication during the course of the study
- Has an uncontrolled infection within the 7 days prior to Screening
- Has undergone treatment with therapeutic oral or IV antibiotics within 2 weeks prior to first dose of study treatment
- Has known active central nervous metastases and/or carcinomatous meningitis. Note: Patients who require steroids for brain metastases must be on a stable or tapering dose of corticosteroids for at least 2 weeks before the first dose of study treatment. If applicable, patients must complete stereotactic radiosurgery 7 days before, and spinal or whole brain radiotherapy 21 days before, their first dose of study treatment
- Has as other primary malignancies that have required systemic antineoplastic treatment within 2 years prior to Screening, except for localized cancers that have apparently been cured (eg, nonmelanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast) and will not interfere with the study outcomes
- Has uncontrolled or significant cardiovascular disease
Key Trial Info
Start Date :
May 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06090318
Start Date
May 19 2023
End Date
May 30 2023
Last Update
October 19 2023
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