A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM

NCT05918107 | Recruiting Phase 2

• 1 other identifier: PM8002 -B003C-MPM-R
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM.

Conditions

MPM

Keywords

First line

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

  : Up to approximately 2 years

• Treatment related adverse events (TRAEs)

  The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0.

  Up to 30 days after last treatment]

Secondary Outcomes (4)

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DoR)

  Up to approximately 2 years

• Progression free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Study Arms (1)

PM8002+pemetrexed+platinum

OTHER

Subjects will be administered with PM8002 plus pemetrexed+platinum via intravenously (IV) Q3W for 4-6 cycles,followed by PM8002 until disease progression intolerable toxicity for a maximum of 2 years.

Drug: PM8002; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Interventions

PM8002 DRUG

IV infusion

PM8002+pemetrexed+platinum

Pemetrexed DRUG

IV infusion

PM8002+pemetrexed+platinum

Cisplatin DRUG

IV infusion

PM8002+pemetrexed+platinum

Carboplatin DRUG

IV infusion

PM8002+pemetrexed+platinum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures;
• Male or female, aged ≥18 years;
• Malignant mesothelioma confirmed by histology, without indication for surgery;
• Have not received systemic anti-tumor therapy in the past (if the subject has received neoadjuvant or adjuvant chemotherapy in the past, the last treatment time must be more than 6 months from the time of recurrence);
• Sufficient organ function;
• Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0-1;
• Expected survival period ≥ 12 weeks;
• There is at least one measurable lesion (malignant pleural mesothelioma is based on mRECIST version 1.1, and malignant mesothelioma in other parts is based on RECIST version 1.1).

You may not qualify if:

• History of severe allergic diseases, severe drug (including unmarked test drug) allergy history, or known allergy to any component of the drug in this study;
• Had other active malignant tumors within 5 years before starting the study drug treatment, except for malignant tumors that can be treated locally and cured (such as skin basal cell or squamous cell carcinoma, superficial or non-invasive bladder cancer), cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma);
• Currently there are uncontrollable pleural, pericardial, and peritoneal effusions, and those with catheter drainage also need to be excluded;
• Unexplained fever \> 38.5°C before starting the study treatment (judged by the investigator, fever caused by tumor can be included in the group);
• There is uncontrollable tumor-related pain, and those who need analgesic treatment should have a stable analgesic treatment plan at the time of screening; asymptomatic metastatic lesions, if they grow further, may cause dysfunction or intractable pain (such as current and spinal cord compression unrelated epidural metastases), local therapy should be considered before screening if appropriate;
• Currently have clear interstitial lung disease or non-infectious pneumonia, except radiation pneumonitis caused by local radiotherapy;
• There are active infections;
• Have a history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies;
• Positive for syphilis antibody;
• Expect to receive any other forms of anti-tumor drug treatment during the trial period;
• Those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past;
• Pregnant or lactating women;
• According to the investigator's judgment, the subject's basic condition may increase the risk of receiving the study drug treatment, or cause confusion for the explanation of the toxic reaction and AE;
• Other investigators think that they are not suitable to participate in this trial.

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (1)

Jilin Provincial Tumor Hospital

Changchun, China

RECRUITING

MeSH Terms

Interventions

Pemetrexed; Cisplatin; Carboplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Ying Cheng

  Jilin Provice Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linlin Fan

CONTACT

+86 18612186005; fan.ll@biotheus.com

Ying Cheng

CONTACT

+86 431 80596065; jl.cheng@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: August 13, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the trial completed
• Access Criteria: NCI is committed to sharing data in accordance with NIH policy

Locations

CN (1)