Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This trial has one experimental arm with two parts: Dose Escalation and Dose Expansion. Participants will receive CYH33 in combination with Olaparib; 20 mg CYH33 QD in combination with olaparib 300 mg BID. Two additional dose levels of CYH33 at 30 mg QD and CYH33 at 40 mg QD in combination with olaparib 300 mg BID will be evaluated. Treatment will be administered orally.
Conditions
This trial is treating people with advanced solid cancer
Eligibility
Inclusion
Patients eligible for inclusion in this study have to meet all of the following criteria:
- Provide informed consent voluntarily.
- Male and female patients ≥ 18 years of age (or having reached the age of majority according to local laws and regulations, if the age is > 18 years).
-
Patients with advanced solid tumor who have failed at least one line of prior systemic therapy or for whom standard therapy do not exist and meet the following eligibility for the corresponding part of the study:
- Patient must have a histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic solid tumor.
- At least one measurable lesion as per RECIST 1.1. (Ovarian cancer participants must have measurable disease by RECIST 1.1 criteria or evaluable cancer via CA125 GCIG criteria; Prostate cancer participants must have measurable disease by RECIST 1.1 criteria or evaluable cancer via PSA response).
-
Population eligibility:
- Availability of tumor tissue sample (either fresh tumor biopsy or archival tumor tissue sample) or blood samples.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Exclusion
Patients eligible for this study must not meet any of the following criteria:
- Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.
- Patients with contraindication to olaparib treatment or who did not tolerate olaparib previously.
- Patients who had prior treatment with PARP inhibitor, PI3Kα inhibitor, AKT inhibitor or mTOR inhibitor (Part 2 dose expansion cohort 1& 2 only).
- Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
- Any toxicities from prior treatment that have not recovered to baseline or ≤ CTCAE Grade 1 before the start of study treatment, with exception of hair loss.
- Patients with an established diagnosis of diabetes mellitus including steroid-induced diabetes mellitus.
- Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
Inclusion
- You are able to swallow medication by mouth.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Haihe Biopharma Co., Ltd.
Scientific Title
Open Label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of CYH33, an Oral PI3K Inhibitor in Combination With Olaparib, an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information