Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Stomach Neoplasms

Carcinoma

Lung Neoplasms

Adenomatous Polyposis Coli

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Diseases

Neoplastic Processes

Polyps

Adenomatous Polyps

Adenoma

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Stomach Cancer

Familial Adenomatous Polyposis

MYH-associated Polyposis

Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs) or Microsatellite Stable (MSS) Colorectal Cancer (Irrespective of WPAM Status)

Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)

Non-Small Cell Lung Cancer with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin

Gastric Cancer/Gastroesophageal Junction Carcinoma (GEJ) with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin

Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs)

FOG-001 will be administered IV once weekly at assigned doses in continuous cycles of 28 days

FOG-001

FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 28 days

Clinical Trial Inquiries

Sunil Sharma, MD

Michael Cecchini, MD

Samuel Klempner, MD

Moh'd Khushman, MD

Shivaani Kummar, MD

Meredith S Pelster, MD

Jordi Rodon Ahnert, MD/PhD

Kyriakos Papadopoulos, MD

Keith Orford, MD, PhD

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.

This first-in-human, Phase 1/2, multicenter, open-label, non-randomized dose escalation and expansion study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of FOG-001 in participants with locally advanced or metastatic solid tumors. FOG-001 is a first-in-class direct inhibitor of Beta-catenin, which functions by blocking its interaction with the T-cell factor (TCF) family of transcription factors.

FOG-001 in Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0

The rate of objective responses (Partial \& Complete) using RECIST v1.1

Rate of Dose Limiting Toxicities (DLTs) across dose levels

Change in tumor Myc expression (on-study compared to baseline)

Best response to treatment using RECIST v1.1

Time from initial objective response (partial response or complete response) to disease progression

Progression Free Survival (PFS) using RECIST v1.1

Fog Pharmaceuticals, Inc.

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Breast Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Renal Cell Carcinoma

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Dostarlimab

GSK4381562

GSK4428859A

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Pamela N. Munster

Antoinette Tan

Debra L. Richardson

Anthony J Olszanski

Reva Elaine Schneider

Drew W Rasco

Vaia Florou

Samantha Bowyer

John Hilton

Lillian Siu

Ye Guo

Francois Ghiringhelli

Loic Lebellec

Toshihiko Doi

Noboru Yamamoto

Dong-Wan Kim

Byoung Chul Cho

Elena Garralda Cabanas

Victor Moreno Garcia

María José de Miguel Luken

Javier García Corbacho

Natalie Cook

Johann S De Bono

GSK Clinical Trials

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of GSK4381562 in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

3 Dose Escalation arms (Arm A: GSK4381562 alone; Arm B: GSK4381562 plus dostarlimab; Arm C: GSK4381562 plus dostarlimab plus GSK4428859A) and 1 new arm, Arm D (dostarlimab plus GSK4428859A). Additional participants may be enrolled in any study arms A, B or C in PK/Pharmacodynamic (PD) cohorts at putative recommended Phase 2 dose (RP2D) level and/or at previously cleared dose levels (up to 15 participants).

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

IPD for this study will be made available via the Clinical Study Data Request site.

Number of participants with adverse events leading to permanent discontinuation of study treatment or withdrawal from study by overall frequency will be assessed.

Overall response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.

GlaxoSmithKline

Pancreatic Neoplasms

Pancreatic Cancer

Stage I: Dose Escalation and dose expansion： Dose Escalation：SYSA1801 will be administered intravenously (IV) at different dose levels, including 0.5, 1, 2, 3, 4.5 and 6 mg/kg according to a modified 3+3 dose-escalation design. Accelerated dose titration design will be used for the first 2 dose levels (0.5 and 1 mg/kg), and then traditional 3+3 dose escalation design will be used for the following levels (2, 3, 4.5 and 6 mg/kg).

Dose expansion: SYSA 1801 will be administered at up to dose levels which is equal or lower than MTD IV infusion. Each dose level contains no more than 12 subjects (including subjects in dose escalation) Stage II: Extension cohort This cohort will comprise subjects with Claudin 18.2 positive GC or GEJ adenocarcinoma, pancreatic cancer or other solid cancer with prior failure of, progression on, or intolerance to, standard therapy.

The starting dose of SYSA1801 for expansion will be derived from the RP2D determined during Stage I

SYSA1801 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.

SYSA1801 for injection

Shen Lin, Ph.D

Gong Jifang, Ph.D

Gong Jifang, PhD.

This is an open-label, dose escalation, dose expansion and extension cohort phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of SYSA1801

This study includes two stages. The dose escalation and dose expansion part (Stage I) will determine the MTD and RP2D of SYSA1801 in subjects with advanced solid tumor for which there is no available standard likely to confer clinical benefit based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design) The extension cohort (Stage II) will evaluate the preliminary efficacy and safety of SYSA1801 in subjects with Claudin 18.2 positive gastric cancer (GC), gastroesophageal junction (GEJ) cancer, pancreatic cancer, non-small cell lung cancer and other solid tumors who have relapsed and/or are refractory to approved therapies.

Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor

A Phase I Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Initial Efficacy of SYSA1801 in the Treatment of CLDN 18.2 Positive Advanced Malignant Solid Tumor

DLT was defined as ≥grade 3 adverse events (per protocal and NCI CTCAE 5.0)related to the study drug that occurred in the first administration cycle (21 days) of SYSA1801

RP2D may be selected based on the Maximum tolerated dose(MTD), pharmacokinetic and antitumor activity data

The adverse events occurring or worsening on or after the first dose of the study drug will be recorded

Cmax of SYSA1801, total antibodies and free MMAE

Tmax of SYSA1801, total antibodies and free MMAE

AUC of SYSA1801, total antibodies and free MMAE

Antibodies against SYSA1801, including neutralizing antibodies

ORR was defined as the proportion of patients achieving either a confirmed complete response or partial response (PR), per RECIST v1.1

DCR is the proportion of patients with disease control (include patients with Complete response, partial response and stable disease)

PFS is defined as the time from the date of first administration to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first.

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Melanoma

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

AMG 355

Amgen Call Center

The primary objectives of this study are to:

* Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors
* Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.

Amgen

Esophageal Neoplasms

Esophageal Cancer

Participants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

BL-B01D1

Hai Zhu, PHD

Sa Xiao, PHD

Lin Shen, PHD

Li Chen

Meili Sun

Qing Wen

Xuelei Ma

Diansheng Zhong

Ji Zhu

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1.

In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated.

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor

DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle .

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1

TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1 .

Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated

Half-life (T1/2) of BL-B01D1 will be investigated

AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

CL in the serum of BL-B01D1 per unit of time will be investigated

Ctough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered

Incidence and titer of ADA of BL-B01D1 will be evaluated

Incidence and titer of Nab of BL-B01D1 will be evaluated.

ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOG-001 in Locally Advanced or Metastatic Solid Tumors	NCT05919264	Cancer Colorectal Canc... Solid Tumor Locally Advance... Metastatic Canc... Gastric Cancer Non-small Cell ... Non-small Cell ... Non-small Cell ... Non-small Cell ... Non-Small Cell ... Gastroesophagea... WNT Pathway β-catenin Beta-catenin Adenomatous Pol... APC	FOG-001 FOG-001	18 Years -	Fog Pharmaceuticals, Inc.
First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors	NCT05277051	Neoplasms	GSK4381562 Dostarlimab GSK4428859A	18 Years -	GlaxoSmithKline
Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor	NCT05009966	Advanced Solid ... Gastric Cancer ... Gastroesophagea... Pancreatic Canc...	SYSA1801 for in...	18 Years - 75 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors	NCT06131398	Advanced Solid ...	AMG 355 Pembrolizumab	18 Years - 100 Years	Amgen
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor	NCT05262491	Gastrointestina...	BL-B01D1	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor	NCT05009966	Advanced Solid ... Gastric Cancer ... Gastroesophagea... Pancreatic Canc...	SYSA1801 for in...	18 Years - 75 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Spots Global Cancer Trial Database for gastric cancer (gc)