Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle.

Administered orally, once a day, 28 days per cycle

ICP-033 tablet

Feng Bi

A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-033 Tablets in Patients with Advanced Solid Tumors.

A Study of ICP-033 in Patients With Advanced Solid Tumors

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors

To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.

To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.

To evaluate the preliminary anti-tumor activity of ICP-033.

Beijing InnoCare Pharma Tech Co., Ltd.

Antineoplastic Agents

All Drugs and Chemicals

Interleukin-12

Adjuvants, Immunologic

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Human single chain IL-12 mRNA-single dose

Human single chain IL-12 mRNA-multiple dose

human single chain IL-12 mRNA administered as specified in the treatment arm with injection once only

human single chain IL-12 mRNA-single dose

human single chain IL-12 mRNA administered as specified in the treatment arm with injection once per week for 3 weeks

human single chain IL-12 mRNA-multiple dose

Dawei Wu, Doctor

Ning Li

Ning Li, Doctor

Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection.

The primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.

ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

An Open-blind Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

Number of Participants Experiencing dose-limiting toxicities (DLTs)

Number of Participants Experiencing Adverse Events (AEs)

Number of Participants Experiencing Severe Adverse Events (SAEs)

Maximum observed concentration (Cmax) of ABOD2011

Area under the concentration-time curve (AUC) of ABOD2011

Maximum observed concentration (Cmax) of IL-12

Area under the concentration-time curve (AUC) of IL-12

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Infections

All Conditions

Virus Diseases

Part A: Dose escalation Part B: Dose expansion

Part A Dose Escalation to assess safety and tolerability of ascending dose levels, define the maximum tolerated dose (MTD), and expansion dose(s) Part B Dose Expansion to further assess safety and tolerability of 1 or more dose levels

Treatment with ICVB-1042 administered intravenously

IconOVir Study Team

Julie Maltzman, MD

Study to evaluate the safety and tolerability of intravenous ICVB-1042

Safety and Tolerability of Intravenous Administration of ICVB-1042

Phase 1 First-in-Human Dose Escalation and Expansion Study to Assess Safety and Tolerability of Intravenous Administration of ICVB-1042 in Patients With Advanced Solid Tumors

ICVB-1042 concentration in urine, feces, and saliva

Number of patients with complete response, partial response, stable disease or progressive disease will be assessed by tumor imaging

Measurement of ICVB-1042 in biopsy samples

Evaluation of cytokine changes from baseline

Evaluation of infectivity from plasma and saliva samples

Assessment of treatment-emergent dose limiting toxicity

IconOVir Bio

BMS-275183

The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.

A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

Bristol-Myers Squibb

Pharmaceutical Solutions

Antibodies

Antibodies, Bispecific

Immunoglobulins

Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage

BAT7104

This is a prospective multi-centre, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients with Advanced Solid Tumours in Australia.

BAT7104 in Patients With Advanced Solid Tumours

A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients With Advanced Solid Tumours

Number of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0.

Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.

Any SAE that is judged by the PI or designee to be related to the study medication must be reported regardless of the amount of time since the last dose received. Follow-up information collected for any initial report of an SAE must also be reported to the Sponsor (or its designee) within 24 hours of receipt by the PI or designee.

Maximum observed plasma or serum concentration

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

area under the serum concentration versus time curve from time zero to infinity and to time λ

Amount of drug in the body divided by plasma concentration

Apparent terminal-phase disposition half-life.

George Clinical Pty Ltd

Bio-Thera Solutions

JS007

Pan He, Postgraduate

Yan Shi, PhD

This is an open label, phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS007 in the patients with advanced solid tumors who have progressed after standard of care, or lack of effective standard therapeutic regimen. This study is divided into two periods: dose escalation period, dose expansion period.

Clinical Study of JS007 in Patients With Advanced Solid Tumors

A Phase Ia Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single-dose and Multiple-dose Of JS007 Injection In Patients With Advanced Solid Tumors

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors), including objective response rate (ORR).

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including duration of response (DOR);

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including disease control rate (DCR);

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including progression-free survival (PFS)

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including overall survival (OS);

Expression of CTLA-4 in tumor tissues before administration

Expression of FoxP3 in tumor tissues before administration

Expression of IDO in tumor tissues before administration

mutation of immune related genes in tumor tissues before administration

expression of immune related genes in tumor tissues before administration

The maximum tolerated dose (MTD) is defined as the highest dose at which DLT （Dose-Limiting Toxicity）occurs in \<1/3 subjects

DLT is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 21 days after the first dose (NCI-CTCAE v5.0)

AE is assessed according to NCI-CTCAE 5.0

SAE（Serious adverse event） is assessed according to NCI-CTCAE 5.0

IrAE is assessed according to NCI-CTCAE 5.0

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters peak concentration (Cmax);

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters trough concentration (Ctrough)

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters time to peak (Tmax);

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-t )

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-inf);

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters elimination half-life (t1/2)

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters clearance rate (CL);

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; apparent volume of distribution(Vd)

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters volume of distribution (Vss)

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters mean retention time (MRT)

The number of lymphocyte in peripheral blood before and after administration

The proportion of lymphocyte in peripheral blood before and after administration

concentration of neutralizing antibody (Nab)

Shanghai Junshi Bioscience Co., Ltd.

Patients will be included in cohorts of a minimum of three or six patients to receive PM534 at successively increasing dose levels.

PM534 drug product is provided as a powder for concentrate for solution for infusion, is a sterile, preservative-free, lyophilized white cake in a single-dose vial for reconstitution prior to intravenous infusion.

PM534

Pharma Mar, S.A. Clinical Oncology

The goals of this trial are to identify the dose limiting toxicities, to determine the maximum tolerated dose and the recommended dose of PM534 in patients with advanced solid tumors. All Patients will receive PM534 via intravenous.

This is a prospective, open-label, dose-escalating phase I study in patients with advanced solid tumors. Patients will be included in cohorts of a minimum of three or six patients to receive PM534 at successively increasing dose levels.

PM534 Administered Intravenously to Patients With Advanced Solid Tumors

Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM534 Administered Intravenously to Patients With Advanced Solid Tumors

A fully evaluable patient is a patient evaluable for the primary objective (i.e., determination of the MTD and the RD).

AEs will be graded according to the NCI-CTCAE v.5.

Parameters Labs will be graded according to the NCI-CTCAE v.5.

The direct relationship between PM534 plasma concentration C and the change from baseline in QT corrected according to Fridericia's formula (ΔQTcF) will be assessed using linear mixed effects (LME) models.

Maximum Plasma Concentration (Cmax). Pharmacokinetic analyses will be evaluated in plasma and urine by standard noncompartmental analysis. Compartmental modeling may be performed if appropriate.

Area Under The Concentration-time Curve (AUC). Pharmacokinetic analyses will be evaluated in plasma and urine by standard noncompartmental analysis. Compartmental modeling may be performed if appropriate.

To analyze the expression levels of Plasma AUC(0-t) of response and/or resistance to treatment with PM534

To analyze the expression levels of Plasma Cmax of response and/or resistance to treatment with PM534

To analyze the expression levels of Plasma half life of response and/or resistance to treatment with PM534

To analyze the expression levels of Total body plasma clearance of response and/or resistance to treatment with PM534

To analyze the expression levels of Volume of distribution of response and/or resistance to treatment with PM534

To analyze the expression levels of Percentage of dose recovered in urine of response and/or resistance to treatment with PM534

To analyze the response rates will be determined in patients with measurable or evaluable disease specific tumor types, time-to-event parameter will also be analyzed ORR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ICP-033 in Patients With Advanced Solid Tumors	NCT05367232	Patients With A...	ICP-033 tablet	18 Years - 75 Years	Beijing InnoCare Pharma Tech Co., Ltd.
ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy	NCT05392699	Patients With A...	human single ch... human single ch...	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Safety and Tolerability of Intravenous Administration of ICVB-1042	NCT05904236	Patients With A...	Treatment with ...	18 Years -	IconOVir Bio
Safety and Tolerability of Intravenous Administration of ICVB-1042	NCT05904236	Patients With A...	Treatment with ...	18 Years -	IconOVir Bio
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies	NCT00207025	Tumors	BMS-275183	18 Years -	Bristol-Myers Squibb
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies	NCT00207025	Tumors	BMS-275183	18 Years -	Bristol-Myers Squibb
BAT7104 in Patients With Advanced Solid Tumours	NCT05200013	Patients With A...	BAT7104	18 Years -	Bio-Thera Solutions
Clinical Study of JS007 in Patients With Advanced Solid Tumors	NCT05049265	Patients With A...	JS007	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
BAT7104 in Patients With Advanced Solid Tumours	NCT05200013	Patients With A...	BAT7104	18 Years -	Bio-Thera Solutions
PM534 Administered Intravenously to Patients With Advanced Solid Tumors	NCT05835609	Patients With A...	PM534	18 Years -	PharmaMar

Spots Global Cancer Trial Database for patients with advanced solid tumors