Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Prostatic Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Triple Negative Breast Neoplasms

Melanoma

Carcinoma, Renal Cell

Carcinoma, Transitional Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Breast Diseases

Head and Neck Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

XmAb®808 in combination with pembrolizumab

XmAb®808

Keytruda® (pembrolizumab)

Michael Chiarella

Amber Sarot

Chet Bohac, MD

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.

This is a Phase 1, open-label, first-in-human (FIH), multiple-dose, dose escalation study with cohort expansion at the RD, designed to evaluate the safety and tolerability of XmAb808 in combination with pembrolizumab. This study will be conducted in 2 parts: Part A (dose escalation) and Part B (cohort expansion).

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

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors

Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings

Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen

Area under the plasma concentration versus time curve (AUCtau)

Objective response rate by RECIST 1.1 assessment of CT/MRI imaging, as modified by PCWG3 for participants with prostate cancer

Progression-free survival by RECIST 1.1 assessment of CT/MRI imaging, as modified by PCWG3 for participants with prostate cancer

Duration of Response by RECIST 1.1 assessment of CT/MRI imaging, as modified by PCWG3 for participants with prostate cancer

Xencor, Inc.

The dose escalation phase includes 10 dose levels of LVGN6051, and the highest dose is up to 10mg/kg. Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits.

LVGN6051

KEYTRUDA® (pembrolizumab)

Lynn Jiang, PhD

Bao-An Huynh

Marjan Rajabi

Mariela Abad, CCRC

Juan Pablo Gómez, MPH

Josh Settlemire, MSN

Amy Ciriaco

Lynda Nelson, MA

LVGN6051 is a humanized monoclonal antibody that specifically binds to CD137, and acts as an agonist against CD137.

This first in human study of LVGN6051 is designed to establish the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) as well as the recommended Phase 2 dose(s) (RP2D) of LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Pembrolizumab/MK-3475) in the treatment of advanced or metastatic malignancy.

This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RDE and RP2D of LVGN6051 as a single agent (monotherapy) and in combination with pembrolizumab (MK-3475). The first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of the study is the dose expansion phase (i.e., Phase 1b). During the study, dose interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are not permitted. Intra-patient dose escalations will be allowed for the early dose cohorts (single-patient dose groups) in Phase 1a Part 1. Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN6051 or pembrolizumab (MK-3475) at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 2 years, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression.

Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy

An Open Label, First in Human (FIH), Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy

mEvaluate the safety and tolerability and determine the Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and recommended Phase 2 dose(s) (RP2D) of LVGN6051 administered as a single agent (monotherapy) and in combination with pembrolizumab, in adult patients with advanced malignancy.

Merck Sharp & Dohme LLC

Lyvgen Biopharma Holdings Limited

Adenocarcinoma

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Leucovorin

Fluorouracil

Capecitabine

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

An accelerated titration design will be employed, and 1 patient will be enrolled initially at each of the lower dose levels: 0.1 mg/kg, 0.3 mg/kg and 1 mg/kg. At Dose Level 4 (3 mg/kg), the standard 3+3 design will be implemented.

Two dose levels will be explored with at least 10 patients in each; the recommended dose for expansion (RDE) from Part A, and another dose level. The RDE may be the MTD or a lower dose level. Additional dose levels and regiments such as, Q2W and/or Q3W dose evaluations may be performed.

Part C, Cohort 1: Patients with m/a GC/GEJ-C, that have progressed under first line (1L) SOC chemotherapy +/- ICI, and are treatment naïve to CLDN18.2 targeting agents and are eligible for second line (2L) treatment. Patients will receive PT886 in combination with Paclitaxel.

Part C, Cohort 2: Patients with m/a PDAC that are treatment naïve for their 1L treatment. Patients will receive PT886 in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).

Patients enrolled in Part C and D of the study must present with ≥ 10% CLDN18.2 positive TC in their tumors.

Part D, Cohort 3: Patients with m/a GC/GEJ-C who have progressed under 1L or 2L SOC chemotherapy +/- ICI and are treatment naïve to CLDN18.2 targeting agents. Patients will receive PT886 in combination with KEYTRUDA® (pembrolizumab).

Part D, Cohort 4: 1L treatment of patients with HER2 negative m/a GC/GEJ-C, that are treatment naïve to CLDN18.2 targeting agents. Patients will receive PT886 in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).

Part D, Cohort 5: Patients with m/a GC/GEJ-C, that have progressed under 1L SOC chemotherapy, and zolbetuximab, and are treatment naïve to KEYTRUDA® (pembrolizumab) or other ICI therapy for their m/a disease. Patients will receive PT886 in combination with KEYTRUDA® (pembrolizumab).

Patients enrolled in Part C and D of the study must present with ≥ 10% CLDN18.2 positive TC in their tumors.

PT886 monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47.

PT886

Chemotherapy as a combination partner to PT886 in Part C: Cohort 1

Chemotherapy as a combination partner to Abraxane and PT886 in Part C: Cohort 2

Chemotherapy as a combination partner to Gemcitabine and PT886 in Part C: Cohort 2

Abraxane

Immune checkpoint inhibitor as a combination partner to PT886 in Part D: Cohort 3, 4, and 5.

Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and PT886 in Part D: Cohort 4

Phanes Therapeutics

Jason Henry, MD

Harshabad Singh, MD

Michael Overman, MD

Z. Esra Cobanoglu, MD

Blake Patterson

Alexander Spira, MD, PhD, FACP

This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886.

Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC).

PT886 For Treatment of Patients With Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study)

A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction (GEJ), or Pancreatic Ductal AdEnocarcinomas of PT886, in Combination With Either ChemotherApy, and/or the ChecKpoint Inhibitor Pembrolizumab TWINPEAK Study

Monitor grade 3 and higher related adverse events.

Interleukin-12

XmAb662

Benjamin Thompson, MD, PhD

Ines Hoffmann

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous administration of XmAb662 monotherapy or in combination with pembrolizumab in subjects with advanced solid tumors and to identify the recommended dose regimen that is safe and biologically effective for XmAb662.

This is a first-in-human (FIH), Phase 1, open-label, multicenter dose escalation study with cohort expansion at one or more recommended dose(s) (RDs), designed to evaluate the safety and tolerability of XmAb662 monotherapy or in combination with pembrolizumab in subjects with selected solid tumors that have progressed after standard/approved therapies, or for which there are no effective available therapies. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2), and subdivided into arms for XmAb662 monotherapy and XmAb662+pembrolizumab combination.

A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors

Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the recommend dose(s)

Objective response rate by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer

Progression-free survival by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer

Duration of response by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter

Q901

KEYTRUDA® (pembrolizumab) will be administered Q6W

Qurient Clinical Trial Information

See Central Contact

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors	NCT05585034	Head and Neck S... Melanoma Exclud... Non-small Cell ... Urothelial Carc... Renal Cell Carc... Castration-resi... Ovarian Cancer,... TNBC - Triple-N... Colorectal Canc...	XmAb®808 Keytruda® (pemb...	18 Years -	Xencor, Inc.
Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy	NCT04130542	Cancer	LVGN6051 KEYTRUDA® (pemb...	18 Years -	Lyvgen Biopharma Holdings Limited
PT886 For Treatment of Patients With Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study)	NCT05482893	Gastric or Gast... Pancreatic Duct...	PT886 Paclitaxel Gemcitabine Abraxane KEYTRUDA® (pemb... Oxaliplatin Leucovorin Fluorouracil Capecitabine	18 Years -	Phanes Therapeutics
A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors	NCT05996445	Solid Tumors	XmAb662 Keytruda® (pemb...	18 Years -	Xencor, Inc.
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors	NCT05394103	Advanced Cancer Metastatic Canc...	Q901 KEYTRUDA® (pemb...	18 Years -	Qurient Co., Ltd.
Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy	NCT04130542	Cancer	LVGN6051 KEYTRUDA® (pemb...	18 Years -	Lyvgen Biopharma Holdings Limited

Spots Global Cancer Trial Database for keytruda® (pembrolizumab)