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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

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

Phase: Phase II/III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: MARIA ZAMUDIO
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 I
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 I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Fady Bertan
Investigator: Antoni Ribas, MD
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 Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: MARIA ZAMUDIO
Investigator: Antoni Ribas, MD
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

A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations

The objective of this study is to evaluate the efficacy of FORE8394 in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with recurrent high-grade glioma (HGG) harboring BRAF V600E mutation. This will be conducted as two single arm open-label subprotocols (F8394-201A; F8394-201B) under one master protocol.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children
Contact: Stacy Zamora
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
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

A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. The study will consist of a dose escalation and a dose expansion stage.

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

XTX202 in Patients With Advanced Solid Tumors

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: THU LY
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

HERSTORY: Hereditary Exploration and Research for Screening and Testing for Oncology Risks in Women

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: Jenny Lester
Open Actively Recruiting

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

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

A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors

Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab. The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, mCRPC, melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled.

Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years. Tumor assessments are performed every 8 weeks for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD). Participants will be followed for safety throughout the study. .

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

A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

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

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Jessica Crocker