Afuresertib +Sintilimab+Chemotherapy in Patients With Selected Solid Tumors That Resistance to Pr… (NCT05383482) | Clinical Trial Compass
CompletedPhase 1/2
Afuresertib +Sintilimab+Chemotherapy in Patients With Selected Solid Tumors That Resistance to Prior Anti-PD-1/PD-L1
China22 participantsStarted 2022-07-01
Plain-language summary
This is a multicenter, open-label, dose-escalation and efficacy/safety Phase I/II study to assess RP2D, safety, tolerability and anti-tumor activity of Sintilimab + afuresertib + nab-paclitaxel or docetaxel administered as a combination therapy.
This study is designed to identify the MTD and recommended Phase II dose (RP2D) of afuresertib in combination with sintilimab and nab-paclitaxel or docetaxel, respectively, to characterize the PK profile of afuresertib in phase I and to evaluate clinical efficacy and safety of the combination therapy in phase II. The study population in phase II is the patients with one of the five selected cancers who resistant to the prior anti-PD-1/PL-1 treatments (as a monotherapy or in combination with other anti-cancer drugs including chemotherapy) , such as EC, GC/GEJC, EsC, CC, and NSCLC.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be \>=18 years of age on the day of signing the informed consent and be able to provide written informed consent for the trial.
✓. Prior treatments:
✓. Tumor diagnosis:
✓. Biomarker test:
✓. Patients who are suitable for nab-paclitaxel or docetaxel judged by investigator.
✓. Have measurable disease per RECIST 1.1 as assessed by local radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
✓. Have adequate organ function as defined below. Specimens must be collected within 10 days prior to the start of study treatment.
Exclusion criteria
✕. Pregnancy or lactation. A woman of child-bearing potential, who has a positive urine pregnancy test prior to treatment. If the urine test is cannot be confirmed as negative, a serum pregnancy test will be required.
What they're measuring
1
Phase I: Frequency and severity of Adverse Events (AEs),including incidence rate of DLTs
Timeframe: Through study completion for an average of 12 months
2
Phase I: Recommended Phase II dose
Timeframe: about 12 months
3
Phase II: Overall Response Rate (ORR) based on RECIST 1.1
Timeframe: Change from Baseline beginning at Cycle 3 Day 1 and then every 6 weeks × 18weeks then every 9 weeks through study completion, an average of 2 years (each cycle is 21 days)
✕. Prior anti-cancer treatment or any investigational agent within 28 days (or 5 half-lives, whichever is shorter) prior to the first dose of study drugs.
✕. Patients that have previously received AKT or PI3 kinase pathway or mTOR inhibitors will not be enrolled.
✕. Patients that discontinued prior anti PD-1/PD-L1 due to immune related AE.
✕. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
✕. With clinically uncontrolled pleural effusion/ascites (patients who do not need effusion drainage or have no significant increase in effusion 3 days after stopping drainage can be enrolled);
✕. With a tumor compressing the surrounding important organs, compressing the superior vena cava, or invading the mediastinal great vessels, heart, etc.;