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SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

This is a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study is divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Kimberly Kelly
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 I/II
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 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 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 I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Rachel Andes
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

Phase 1a/1b Study of Aplitibart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers

This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitibart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of aplitibart+FOLFIRI+bevacizumab.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
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 I
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 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

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 I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Christopher Hannigan
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

A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.

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

A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Subjects With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression

The goal of this study is to test A2B530,an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A*02 expression.

The main questions this study aims to answer are: - Phase 1: What is the maximum or recommended dose of A2B530 that is safe for patients - Phase 2: Does the recommended dose of A2B530 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: - Enrollment and Apheresis in BASECAMP-1 (NCT04981119) - Preconditioning Lymphodepletion (PCLD) Regimen - A2B530 Tmod CAR T cells at the assigned dose

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

Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Rachel Andes
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 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 Study to Investigate LYL845 in Adults With Solid Tumors

This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).

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

Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Naomi Long-Schmelzle
Open Actively Recruiting

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.

ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) [Part 2i] or mutated EGFR-expression (mutEGFR NSCLC) [Part 2ii], squamous NSCLC [Part 2iii], GEA [Part 3] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion [Part 4], participants MET amplification will receive IV ABBV-400 monotherapy in expansion [Part 5], participants MET mutation will receive IV ABBV-400 monotherapy in expansion [Part 6], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab [Part 7a], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets [Part 7b]. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Heather Horowitz