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

Phase 2

Recruiting

• Conditions: MPM
• Interventions: Drug: PM8002; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

• Registration Number: NCT05918107
• Lead Sponsor: Biotheus Inc.

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.

Detailed Description

PD-L1 and VEGF play important roles in immune escape and tumor angiogenesis and enhance cancer growth and metastasis. PM8002 is a bispecific antibody targeting PD-L1 and VEGF-A. Here, the investigators present the results from a Phase II study of PM8002 in combination with pemetrexed and platinum subjects in unresectable malignant mesothelioma.

Study Timeline

• Study Start: 2022-08-13
• Status Verified: 2023-06
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-25
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-27
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. 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;
2. Male or female, aged ≥18 years;
3. Malignant mesothelioma confirmed by histology, without indication for surgery;
4. 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);
5. Sufficient organ function;
6. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0-1;
7. Expected survival period ≥ 12 weeks;
8. 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).

Exclusion Criteria

1. 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;
2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, judged by the investigators as not suitable for inclusion;
3. 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);
4. Currently there are uncontrollable pleural, pericardial, and peritoneal effusions, and those with catheter drainage also need to be excluded;
5. Unexplained fever > 38.5°C before starting the study treatment (judged by the investigator, fever caused by tumor can be included in the group);
6. 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;
7. Currently have clear interstitial lung disease or non-infectious pneumonia, except radiation pneumonitis caused by local radiotherapy;
8. There are active infections;
9. Have a history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies;
10. Positive for syphilis antibody;
11. Expect to receive any other forms of anti-tumor drug treatment during the trial period;
12. Those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past;
13. Pregnant or lactating women;
14. 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;
15. Other investigators think that they are not suitable to participate in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PM8002+pemetrexed+platinum	PM8002	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.
PM8002+pemetrexed+platinum	Pemetrexed	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.
PM8002+pemetrexed+platinum	Cisplatin	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.
PM8002+pemetrexed+platinum	Carboplatin	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	: Up to approximately 2 years	Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Treatment related adverse events (TRAEs)	Up to 30 days after last treatment]	The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	Up to approximately 2 years	DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Disease control rate (DCR)	Up to approximately 2 years	DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.
Progression free survival (PFS)	Up to approximately 2 years	PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
Overall survival (OS)	Up to approximately 2 years	OS is the time from the date of first dosing date to death due to any cause.

Trial Locations

Locations (1)

Jilin Provincial Tumor Hospital; 🇨🇳 Changchun, China