Advanced solid tumors
Conditions
Interventions
Dose escalation:BAY 2862789
Mini-PAD cohorts:BAY 2862789
Expansion:BAY 2862789
Sponsors
Jilin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: informed consent 1. Able to sign the informed consent form as described in Appendix 1 (Section 10.1.3), including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol; 2. On the date of signing the informed consent, the age of the study participant >=18 years. Study participant type and disease characteristics; 3. Measurable lesions that meet RECIST 1.1 criteria, as assessed by the local study center investigator. Progression of a lesion located in an area previously treated with radiotherapy or local therapy is considered measurable; 4. ECOG performance status score of 0-1; 5. For study participants with a confirmed diagnosis of solid tumors by histological examination, who have exhausted standard therapy known to be beneficial for that tumor type, or are unacceptable to standard therapy, and participation in this trial is a reasonable option to be enrolled. Prior to enrollment in the trial, appropriate tumor molecular characterization should be performed according to local national guidelines. If the study participant has genomic aberrations known to be targetable for therapy, they should also have been treated with available targeted medications as deemed appropriate by the investigator; The criteria for studying the different parts are as follows: 1) Dose escalation: all solid tumors, except primary central nervous system cancer; 2) mini-PAD cohorts: Study participants eligible for these cohorts must have received prior appropriate anti-PD-1/PD-L1 therapy. These study participants must have had an imaging response or achieved stable disease status within the first 12 weeks of treatment with this regimen and subsequently had disease progression while receiving this regimen (study participants are also eligible if they continue to receive an anti-PD1/L1-containing regimen with subsequent remissions); The mini-PAD cohort can enroll the following tumor types: (1) NSCLC: Study participants must have received up to two lines of standard therapy (including platinum-containing regimens) for metastatic disease. Study participants with disease progression within 6 months of completion of adjuvant treatment with approved anti-PD-1/PD-L1 agents are eligible to participate in the study. NSCLC study participants harboring EGFR or ALK mutations; Not eligible for selection (2) Gastric/GEJ adenocarcinoma: Study participants have received up to two lines of standard therapy for metastatic disease. If HER2 is positive, study participants must have received anti-drugs Standard therapy for HER2, allowing prior receipt of up to three prior lines of HER2-targeted therapy; (3) MMR-deficient/MSI high-instability CRC tumors: MSI high-instability, as determined by local standard treatment, MSI high-instability status (based on local approved/licensed methods obtained from patient records, e.g., historical test results for FoundationOne CDx, OncoMateMSI Dx, VENTANA MMR RxDx Panel, Guardant360 CDx). Study participants in this cohort can receive up to three lines of standard therapy; (4) Melanoma: BRAF-negative study participants who have received up to two lines of standard therapy for metastatic disease. BRAF-positive swelling that has received up to three lines of therapy; Tumor study participants. BRAF-positive tumor study participants who have not received BRAF inhibitor monotherapy or in combination with a MEK inhibitor due to unacceptable or unavailable targeted therapy are also eligible to particip
Exclusion criteria
Exclusion criteria: Study participants who meet any of the following criteria must not be enrolled in this study: Medical conditions 1. Must have a negative result of a highly sensitive pregnancy test (urine or serum pregnancy test as required by local regulations) from WOCBP within 24 h (urine) or 72 h (serum) prior to the first dose of study treatment. If a negative urine test cannot be confirmed (e.g., results are inconclusive), a serum pregnancy test is required. In this case, if the serum pregnancy test result is positive, the study participant must be excluded from the study; 2. Received allogeneic tissue/solid organ transplantation; Prior/concomitant therapy 3. Prior treatment with a DGK inhibitor; 4. Prior treatment regimen containing anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or targeting other stimulatory or co-inhibitory T-cell receptor agents (e.g., CTLA-4, OX 40, CD137) and discontinued treatment due to Grade 3 or above irAEs or any life-threatening toxicity; 5. Received systemic anti-tumor therapy, including investigational agents, within 4 weeks or 5 half-lives (whichever is shorter) prior to treatment. Growth factor therapy such as G-CSF must be discontinued 4 weeks prior to enrollment in the study; Note: All AEs that occurred during prior therapy (systemic therapy) in study participants must have recovered to Grade =1 or baseline. Study participants with Grade =2 neuropathy and/or alopecia may be enrolled in the study, and study participants =with Grade 2 endocrine-related AEs requiring treatment or hormone replacement may be enrolled in the study. Note: If the study participant has undergone major surgery, any toxicity and/or complications resulting from the surgery must have fully recovered before initiating study treatment 6. Study participants must have recovered from previous toxicity due to radiotherapy, do not require corticosteroids, and have not had radiation pneumonitis; 7. Study participant has not had a blood transfusion within 2 weeks prior to initiation of treatment; 8. Vaccination with a live vaccine within 30 days prior to the first dose of study drug, examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines for injection are generally inactivated virus vaccines and are therefore permitted; However, intranasal influenza vaccines (e.g., FluMist®) are live-attenuated vaccines and are not allowed; Previous/contemporaneous clinical study experience 9. Currently enrolled, or has participated in, a study of an investigational drug or investigational device within 4 weeks prior to the first dose of study treatment; Note: For study participants who have entered the follow-up period of the pilot study, if it has been 4 weeks since the last dose of the last trial drug, they can participate in this study; Diagnostic evaluation 10. Diagnosed immunodeficiency, or is receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 11. Known other malignancies with disease progression or need for active treatment within the past 3 years; Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, urothelial carcinoma, transitional cell carcinoma, or carcinoma in situ (e.g., breast cancer, cervical cancer in situ) study participants who have received potentially curative therapies do
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of remission;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactCheng Ying
Jilin Cancer Hospital
Outcome results
None listed