RECRUITINGPhase 1INTERVENTIONAL
Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors
A Phase Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYN818 With Olaparib in Patients With Locally Advanced or Metastatic Solid Tumors
About This Trial
This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 with Olaparib in adult patients with locally advanced or metastatic solid tumors
Who May Be Eligible (Plain English)
Who May Qualify:
- Having signed the written willing to sign a consent form Form (ICF);
- Male or female aged ≥18 years;
- Life expectancy ≥12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;
- Participant has a diagnosed by tissue sample (biopsy-confirmed) diagnosis of advanced or metastatic solid tumor and has exhausted all standard-of-care treatment options, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 1).
- Participant has diagnosed by tissue sample (biopsy-confirmed) locally advanced or metastatic epithelial ovarian cancer or HER2-negative breast cancer, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 2).
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;
- your organs (liver, kidneys, etc.) are working well enough based on blood tests and bone marrow function.
Who Should NOT Join This Trial:
- Previous or current use of DNA Polymerase Theta (POLQ) inhibitors;
- Current or previous other malignancy unless treated radically and with no evidence of recurrence or metastasis within the past 5 years;
- Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;
- Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML;
- Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;
- Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Having signed the written Informed Consent Form (ICF);
* Male or female aged ≥18 years;
* Life expectancy ≥12 weeks;
* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;
* Participant has a histologically confirmed diagnosis of advanced or metastatic solid tumor and has exhausted all standard-of-care treatment options, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 1).
* Participant has histologically or cytologically confirmed locally advanced or metastatic epithelial ovarian cancer or HER2-negative breast cancer, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 2).
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
* No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;
* Adequate organ function and bone marrow function.
Exclusion Criteria:
* Previous or current use of DNA Polymerase Theta (POLQ) inhibitors;
* Current or previous other malignancy unless treated radically and with no evidence of recurrence or metastasis within the past 5 years;
* Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;
* Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML;
* Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;
* Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter;
* History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4/BCRP/P-gp during the study;
* Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.
Treatments Being Tested
DRUG
SYN818 and Olaparib will be administered
Patients will orally receive SYN818 and Olaparib
Locations (2)
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China