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Open Actively Recruiting

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

First in Human Study of TORL-4-500 in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of RO7496353 when administered in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The study will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

First in Human Study of TORL-3-600 in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.

The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with tislelizumab or irinotecan that can be given to patients who have cancers with specific molecular alterations called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient) that might work best to treat these specific cancer types and to understand how well HRO761 is able to treat those cancers.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors

The goal of this clinical trial is to test CPO301, a type of drug called an antibody drug conjugate in adult patients with advanced or metastatic solid tumors.

The main questions it aims to answer are: - To assess the safety and tolerability of CPO301 at increasing doses and determine the dose to be used in the second part of the study (Part A) - To assess the safety and tolerability of CPO301 at the dose determined to be safe and tolerable in Part A in patients with Non-Small Cell Lung Cancer and potentially other tumor types (Part B) - To evaluate how quickly CPO301 is metabolized by the body (pharmacokinetics or PK) - To evaluate if antibodies to the study drug develop (immunogenicity) - To evaluate preliminary efficacy to the drug - To correlate preliminary efficacy with mutations in a biomarker called EGFR Participants will: - Provide written informed consent - Undergo screening tests to ensure they are eligible for study treatment - Attend all required study visits and receive CPO301 by intravenous injection every 3 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment - Be followed for progression every 3 months for up to 2 years

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies

This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

First-in-human Study of DB-1305 for Advanced/Metastatic Solid Tumors

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305 in subjects with advanced solid tumors.

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Investigator: Aaron Lisberg, MD
Open Actively Recruiting

A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors

This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Tina Tieu
Open Actively Recruiting

A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors

To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a change in a particular gene (known as the RET gene). Participation could last up to 24 months (2 years) and possibly longer if the disease does not get worse.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CINDY TONG
Open Actively Recruiting

A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies

This is a Phase 2, open-label, parallel 3-cohort, multicenter study to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors

RBS2418 (investigational product) is a specific immune modulator, working through ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine production in the tumors. RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with checkpoint blockade. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours

The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.

The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)

This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO