Actively Recruiting
Phase I Study of AZD5363 + Olaparib + Durvalumab in Patients With Advanced or Metastatic Solid Tumor Malignancies
Led by National University Hospital, Singapore · Updated on 2025-07-22
40
Participants Needed
1
Research Sites
421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1 dose-escalation study to evaluate the safety and tolerability of combination treatment of AZD5363 + Olaparib + Durvalumab and to determine the RP2D in patients with advanced or metastatic solid tumor malignancies. The purpose of this trial is to determine if combination treatment of drugs, Olaparib, AZD5363 and Durvalumab has beneficial effects in advanced or metastatic cancers and to determine the effects it has on patients and their cancer. Primary Objectives • To evaluate the safety and tolerability of combination treatment AZD5363 + Olaparib + Durvalumab and determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicities (DLTs), and Recommended Phase 2 Dose (RP2D) for patients with advanced or metastatic solid tumor malignancies. Secondary Objectives * To determine the pharmacodynamics (PDn) of combination treatment AZD5363 + Olaparib + Durvalumab in patients with advanced or metastatic solid tumor malignancies * To describe anti-tumor response using immune RECIST of combination treatment AZD5363 + Olaparib + Durvalumab in patients with advanced or metastatic solid tumor malignancies Exploratory Objectives * To evaluate anti-tumour response using RECIST v1.1 for combination treatment AZD5363 + Olaparib + Durvalumab in patients with advanced or metastatic solid tumor malignancies * To explore molecular correlates of the relationship between mutations in Akt/ PIK3CA/PTEN pathway and response to AZD5363 +Olaparib+ Durvalumab * To understand the role of tumour microenvironment in regulation of intratumoral immune regulators (i.e. T-regulatory cells) in improving response to Durvalumab * To understand the role of AZD5363 as an immunomodulator * To evaluate the role of PD-1 and PDL-1 immunohistochemical and tumour MMR status in predicting response to immune check point inhibitors.
CONDITIONS
Official Title
Phase I Study of AZD5363 + Olaparib + Durvalumab in Patients With Advanced or Metastatic Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent according to local guidelines
- Age 21 years or older
- Histologically confirmed advanced or metastatic solid tumors with radiologic evidence of progressive disease
- At least 2 measurable tumor lesions
- No expected benefit from further conventional therapy or no standard therapy available
- Provision of archived tumor tissue samples if available
- Any number of prior chemotherapy treatments allowed including biologics
- ECOG performance status of 0 or 1
- Adequate bone marrow and organ function within 2 weeks before treatment
- Females of childbearing potential must use at least two effective contraception methods during study and specified post-treatment period
- Non-sterilized males with partners of childbearing potential must use condom plus spermicide during and after treatment
- At least 4 weeks since major surgery, radiation, or other anti-cancer therapy with recovery to grade 1 or less (except alopecia and neuropathy grade 2 or less)
- Life expectancy greater than 12 weeks
- Weight at least 30 kg
- Previous treatment with checkpoint or PARP inhibitors allowed
You will not qualify if you...
- Significant medical illness that cannot be controlled or would prevent tolerance of study therapy
- Radiation therapy within 3 weeks before first dose except palliative bone radiation
- Participation in another clinical trial with investigational drugs within 30 days before first dose
- Use of certain chemotherapy, immunotherapy, or CYP enzyme affecting drugs within specified timeframes before treatment
- Uncontrolled hypertension or hypertension requiring more than 3 medications
- Significant abnormalities in glucose metabolism including diabetes type I or poorly controlled type II diabetes
- Major surgery within 28 days
- Active or prior autoimmune or inflammatory disorders with exceptions
- Specific cardiac conditions including abnormal ECGs, heart failure, or low ejection fraction
- Uncontrolled infections or illnesses affecting ability to comply with study
- Significant proteinuria or electrolyte abnormalities
- Use of immunosuppressive medications within 14 days before durvalumab except certain steroids
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Known allergies to study drugs or excipients
- History of organ transplant or tuberculosis
- Active infections including hepatitis B, C, or HIV
- Renal failure requiring dialysis
- Concurrent cancers except certain skin or cervical cancers in remission
- Gastrointestinal issues preventing oral medication intake
- Serious psychiatric or medical conditions interfering with treatment
- Prior myelodysplastic syndrome or acute myeloid leukemia
- Requirement for therapeutic anticoagulation with warfarin
- Untreated or unstable brain metastases or spinal cord compression
- Receipt of live attenuated vaccines within 30 days before study entry
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore, Singapore, 119074
Actively Recruiting
Research Team
D
David SP Tan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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