Pancreatic Cancer
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability and efficacy of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in subjects with locally advanced or metastatic pancreatic cancer.
Detailed description
This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in the treatment of patients with unresectable locally advanced or metastatic pancreatic cancer. This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. During the dose exploration phase, RP2D was determined based on the safety, tolerability, and preliminary efficacy data of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy, and then entered the efficacy exploration phase.
Interventions
DRUGSHR-A2102 or/and HRS-4642
Drug: SHR-A2102 SHR-A2102 will be administrated per dose level in which the patients are assigned. Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.
DRUGSHR-A1904 or/and HRS-4642
Drug: SHR-A1904 SHR-A1904 will be administrated per dose level in which the patients are assigned. Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.
DRUGSHR-A1811 or/and HRS-4642
Drug: SHR-A1811 SHR-A1811 will be administrated per dose level in which the patients are assigned. Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.
DRUGSHR-A2102, HRS4642 and Adebrelimab
Drug: SHR-A2102 SHR-A2102 will be administrated per dose level in which the patients are assigned. Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned. Drug: Adebrelimab Adebrelimab will be administrated per dose level in which the patients are assigned.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients volunteered to participate in this study and signed informed consent; 2. Age: ≥18 and ≤75 years old, male or female; 3. Advanced (metastatic or unresectable) pancreatic cancer; and subjects must have at least one measurable lesion as defined by RECIST v1.1; 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 5. Life expectancy ≥ 12 weeks; 6. Adequate marrow and organ function; 7. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;
Exclusion criteria
1. Known to be allergic to the investigational drug or any of its components; 2. Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose; 3. Have other active malignancies within 5 years; 4. Accompanied by untreated or active central nervous system (CNS) metastases; 5. Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended phase II dose (RP2D) | Approximately 12 months | RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages. |
| Objective Response Rate (ORR) | Up to approximately 12 months] | Evaluated by RECIST v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to approximately 12 months | Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free. |
| Disease Control Rate (DCR) | Up to approximately 12 months | Evaluated by RECIST v1.1. |
| Adverse events (AEs) | From the first drug administration to within 90 days for the last ADC durgs dose | AEs are assessed by NCI-CTCAE v5.0 |
| Overall survival (OS) | Up to approximately 12 months | Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive. |
| Duration of Response (DOR) | Up to approximately 12 months | Evaluated by RECIST v1.1. |
Countries
China
Contacts
Primary ContactSi Shi, PHD
Outcome results
None listed