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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

A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor

The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: KATHRYN HILBURN
Open Actively Recruiting

A Clinical Trial of KVA12123 Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)

The goal of this clinical trial is to test the safety and efficacy of KVA12123 alone or combined with pembrolizumab in patients with advanced solid tumors. The main questions this study aims to answer are:

1. What is the safety of KVA12123 when administered alone and in combination with pembrolizumab to advanced cancer patients? 2. What is an appropriate dose of KVA12123 to administer alone and in combination with pembrolizumab to advanced cancer patients in future clinical trials? Participants in this trial will be asked to: 1. Visit the clinical site every 1 - 2 weeks. 2. Receive KVA12123 every 2 weeks alone or in combination with pembrolizumab every 6 weeks. 3. Provide blood samples to evaluate drug levels in blood, drug safety and to explore the effects of each drug on the immune system. 4. Undergo scans every 6 weeks to test the effect of treatment on cancer progression. 5. Undergo other study procedures to evaluate drug safety and participant safety including physical exams, heart function tests, etc.

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

KZR-261 in Subjects With Advanced Solid Malignancies

A first-in-human, open-label, multicenter, Phase 1 study of KZR-261 designed to assess the safety and tolerability, preliminary anti-tumor activity, and pharmacokinetics (PK) of KZR-261, as well as identify the recommended Phase 2 dose (RP2D). The study comprises a Part 1 (Dose Escalation) and a Part 2 (Dose Expansion) in solid organ tumors (melanoma/uveal melanoma, mesothelioma, colorectal cancer, prostate cancer, and "All-Tumors").

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: THU LY
Open Actively Recruiting

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Open Actively Recruiting

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in 490 participants with advanced cancer that has recurred/progressed.

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

Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors

This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.

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

Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers

Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-002 given intravenously every 3 weeks.

Phase: Phase I
Primary Purpose: Treatment
Gender: Female
Age Group: Adults
Contact: ANNABEL LIU
Open Actively Recruiting

ARX517 as Monotherapy and in Combination Regimens in Subjects With Metastatic Castration-resistant Prostate Cancer

This is a phase 1/2 study to assess the safety and tolerability of ARX517 as monotherapy or in combination in adult subjects with Metastatic castration-resistant prostate cancer (mCRPC).

Phase: Phase I/II
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Contact: WHITNEY VUONG
Investigator: John Shen, MD
Open Actively Recruiting

First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-01-097 in patients with advanced solid tumors.

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

Trial of DFP-14927 in Advanced Solid Tumors

This is a Phase I, open-label, single-arm, dose escalation study of DFP-14927 intravenous infusion administered to patients with refractory or relapsed solid tumors.

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

A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies

RSC-101 is a Phase 1a/1b clinical trial of RSC-1255 in adult study participants with advanced solid tumor malignancies who are intolerant of existing therapies known to provide clinical benefit, have disease that has progressed after standard therapy, or have previously failed other therapies. The study has two phases. The purpose of Phase 1a (Dose Escalation) is to confirm the appropriate treatment dose and Phase 1b (Dose Expansion) is to characterize the safety and efficacy of RSC-1255.

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

LYT-200 Alone and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Tislelizumab in Patients with Metastatic Solid Tumors

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

Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer

This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4/6 pathway and that has come back (recurrent). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib may work better for the treatment of recurrent ovarian and endometrial cancer.

Phase: Phase II
Primary Purpose: Treatment
Gender: Female
Age Group: Adults
Contact: ANNABEL LIU
Open Actively Recruiting

Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

Phase: Phase I
Primary Purpose: Basic Science
Gender: All
Age Group: Adults
Contact: JEREMIE CALAIS
Open Actively Recruiting

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Shenetra Walker
Open Actively Recruiting

A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors

Part 1 is the dose escalation of APG-115 in combination with label dose of pembrolizumab.

Part 2 is phase II design of APG-115 at recommended phase 2 dose (RP2D) in combination with pembrolizumab.

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Fady Bertan
Open Actively Recruiting

Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies

The primary objective is to assess the safety and tolerability of TAB004 as monotherapy and in combination with toripalimab in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose.

The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB004 monotherapy and in combination with toripalimab and to describe the PK profile of toripalimab when administered with TAB004, 2) evaluate antitumor activity of TAB004 monotherapy and in combination with toripalimab; and 3) determine the immunogenicity of TAB004 monotherapy and in combination with toripalimab and to determine the immunogenicity of toripalimab when administered with TAB004. The exploratory objectives are to: 1) evaluate pharmacodynamic effects of TAB004 on its target receptor BTLA, as well as effects on the immune system; 2) evaluate biomarkers that may correlate with activity of TAB004 as monotherapy and in combination with toripalimab; 3) evaluate the utility of BTLA ligand, herpesvirus-entry mediator (HVEM), and additional exploratory biomarkers that could aid in selection of appropriate subjects for TAB004 monotherapy and in combination with toripalimab.

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

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D).

Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children