Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th days of each cycle until unacceptable toxicity or disease progression were observed. Each cycle contains 28 days.

PM8002

nab-paclitaxel

Hao Fu

Wu Jiong

Jiong Wu

Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.

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 Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.

A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC

A Phase Ib/II Study of PM8002 Injection Plus Nab-paclitaxel as First Line Therapy for Unresectable, Locally Advanced or Metastatic Triple-negative Breast Cancer

The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.

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

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

DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.

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.

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).

OS is the time from the date of first dosing date to death due to any cause.

Biotheus Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Small Cell Lung Cancer

Subjects will be administered with PM8002 plus Paclitaxel via intravenously (IV) Q3W for 5 cycles, followed by PM8002 until disease progression or intolerable toxicity for a maximum of 2 years.

Jia Song

Ying Cheng

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.

This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy

A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

A Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Paclitaxel Injection as Second Line Treatment for Small Cell Lung Cancer(SCLC)

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

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years.

Subjects will be administered with placebo plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by placebo and pemetrexed until progression or for a maximum of 2 years.

Placebo

Zhang Jie

Wu Yilong

Wu Yilong, PhD

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II/III study to evaluate the efficacy and safety of PM8002 in combination with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed to EGFR-TKI treatment.

The study is divided into two parts. The first part is a phase II, single-arm study, which is planned to enroll 60 subjects. The second part is a phase III randomized, double-blind, placebo-controlled study. The study plans to enroll 314 subjects, who will be randomized in a 1:1 ratio to an experimental group of PM8002 in combination with chemotherapy (pemetrexed and carboplatin) and a control group of chemotherapy (pemetrexed and carboplatin).

A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC

A Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of PM8002(Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With EGFR-mutant Advanced Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.

To assess the Exposure-Response of PM8002 by means of population PK (popPK) analysis

To evaluate correlation between PM8002 exposure, immunogenicity and efficacy

To evaluate correlation between PM8002 exposure, immunogenicity and safety

Progression free survival (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).

OS is the time from the date of randomization or first dosing date to death due to any cause.

ORR is the proportion of subjects with CR or PR, based on RECIST v1.1.

TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1).

The PK parameters include serum concentrations of PM8002 at different timepoints after study drug administration.

To evaluate the incidence of ADA to PM8002

To evaluate correlation between PD-L1 expression and antitumor effect

Breast Diseases

Skin Diseases

Patients will receive both PM8002 and Nab-Paclitaxel.

Patients will receive both Placebo and Nab-Paclitaxel.

PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle

Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle

Nab-Paclitaxel

Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle

Yanqing Cao

Linlin Fan

Jian Zhang, professor

Jiong Wu, professor

This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)

PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer

A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC)

Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.

Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BIRC or investigators based on RECIST 1.1 is presented.

DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by BIRC or investigators using RECIST v1.1

DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.

Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale.

Etoposide

Atezolizumab

Etoposide phosphate

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years.

Subjects will be administered with Atezolizumab plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by Atezolizumab until progression or for a maximum of 2 years.

Platinum

Zhishuo Cheng

Ying Chen

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer

The study is divided into two parts.

The first part is single-arm study, with a planned enrollment of at least 59 subjects.

The second part is randomized, double-blind study, this study plans to enroll 386 subjects, who will be randomized in a 1:1 ratio to an experimental group of PM8002 in combination with chemotherapy (etoposide and platinum) and a control group of Atezolizumab with chemotherapy (etoposide and platinum).

A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC

A Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of PM8002 in Combination With Etoposide and Platinum in First-line Treatment of Extensive-Stage Small Cell Lung Cancer

The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations

Overall survival (OS) is the time from the date of randomization or first dosing date to death due to any cause.

DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1.

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.

The PK parameters including serum concentrations of PM8002 at different time points after study drug administration.

To evaluate the incidence of ADA to PM8002.

Antibodies

Antibodies, Bispecific

Immunoglobulins

PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)

YE GUO

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.

PM8002 in the Treatment of Patients With Advanced Solid Tumors

Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors

DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.

DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1). for subjects with no documented disease progression, the deadline is the data of the last examination.

Progression-free survival is defined as the time from the start of treatment with PM8002 until the first documentation of disease progression or death due to any cause, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC	NCT05918133	TNBC	PM8002 nab-paclitaxel	18 Years - 75 Years	Biotheus Inc.
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC	NCT05879068	SCLC	PM8002 Paclitaxel	18 Years -	Biotheus Inc.
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC	NCT05756972	NSCLC	PM8002 Placebo Carboplatin Pemetrexed	18 Years -	Biotheus Inc.
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer	NCT06419621	Triple Negative...	PM8002 Nab-Paclitaxel Placebo	18 Years - 70 Years	Biotheus Inc.
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC	NCT05918133	TNBC	PM8002 nab-paclitaxel	18 Years - 75 Years	Biotheus Inc.
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC	NCT05844150	SCLC	PM8002 Platinum Atezolizumab Etoposide	18 Years -	Biotheus Inc.
PM8002 in the Treatment of Patients With Advanced Solid Tumors	NCT05918445	Malignant Neopl...	PM8002	18 Years - 75 Years	Biotheus Inc.
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC	NCT05756972	NSCLC	PM8002 Placebo Carboplatin Pemetrexed	18 Years -	Biotheus Inc.

Spots Global Cancer Trial Database for pm8002

Every month we try and update this database with for pm8002 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pm8002

Every month we try and update this database with for pm8002 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pm8002 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.