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Open Actively Recruiting

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig in combination with platinum doublet chemotherapy or datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Dawit Hailu
Investigator: Jay M. Lee, MD
Open Actively Recruiting

EFIRM Liquid Biopsy Research Laboratory: Early Lung Cancer Assessment

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: MEGUMI YOKOMIZO
Open Actively Recruiting

A Study of DB-1311 in Advanced/Metastatic Solid Tumors

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311 in subjects with advanced solid tumors.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Joanna Gutierrez
Investigator: Aaron Lisberg, MD
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 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

Immune Monitoring Following Radiation for Lung Cancer

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: CHRISTY PALODICHUK
Investigator: Jie Deng, MD, PhD
Open Actively Recruiting

Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer

This is an open label, Phase 1, dose escalation trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab in patients with immune checkpoint inhibitor refractory non-small cell lung cancer.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Angela Lool
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 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

A Study of SGN-EGFRd2 in Advanced Solid Tumors

This study will test the safety of a drug called SGN-EGFRd2 in participants with advanced solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

Participants will have cancer that cannot be removed (unresectable) or has spread through the body (metastatic).

This study will have three parts. Parts A and B of the study will find out how much SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B to find out how safe SGN-EGFRd2 is and if it works to treat solid tumor cancers.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Rachel Andes
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 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.

The main question[s] it aims to answer are:

  • the recommended dose for Phase 2
  • to evaluate the safety and tolerability of the combination therapy
  • to determine the pharmacokinetics of TNG260
  • to evaluate the initial antineoplastic activity

Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Angela Lool
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 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer

This is a Phase I open label multi-center study to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of the investigational drug MYTX-011 in patients with locally advanced, recurrent or metastatic NSCLC. MYTX-011 is in a class of medications called antibody drug conjugates (ADCs). MYTX-011 is composed of a pH-dependent anti-cMET antibody and the potent antimicrotubule drug monomethyl auristatin E (MMAE).

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Jenny Choi-Tamanaha
Open Actively Recruiting

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CINDY TONG
Open Actively Recruiting

PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation

This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Angela Lool
Open Actively Recruiting

A Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors

This study will test the safety of a drug called SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

This study will have 3 parts. Parts A and B of the study will find out how much SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if SGN-BB228 is safe and if it works to treat solid tumor cancers.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Fady Bertan
Investigator: Antoni Ribas, MD
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 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Heather Horowitz
Investigator: Aaron Lisberg, MD
Open Actively Recruiting

Phase 3 Clinical Study of AK112 for NSCLC Patients

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of Ivonescimab (SMT112 or AK112) or Placebo Plus Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Angela Lool
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 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Chris Hannigan