Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Small Cell Lung Carcinoma

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Lung Neoplasms

Carcinoma

Neoplasms, Squamous Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Small Cell Lung Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Antibodies, Bispecific

Immunoglobulins

Immunologic Factors

Dose-escalation phase: the dosing schedule of IMM2520 is 0.1 mg/kg, 0.4 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg and 6.0 mg/kg sequentially.

IMM2520 will be administered once a week intravenously at Day 1, Day8, Day 15 and Day 22 each cycle for up to 48 weeks.

IMM2520

Ping Zhou, MM

YIXUAN YANG, MD

Yuping Sun, PI

This is a multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM2520 in subjects with advanced solid tumors.

IMM2520 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle).

The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase.

Once the RP2D is determined, Simon's two-stage design will be used to explore for each specific tumor cohort.adenocarcinoma/esophageal cancer, urothelial cancer, and/or others.

This study is to observe the dose-limiting toxicity (DLT) of the patients and to determine the maximal tolerance dose(MTD) and recommended dose for expansion (RDE)

IMM2520, a PD-L1 and CD47 Bispecific Antibody in Patients With Advanced Solid Tumors

A Phase 1 Clinical Study to Evaluate IMM2520 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Advanced Solid Tumors

Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs)

To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of IMM2520 in subjects with advanced solid tumors.

ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)

DCR is defined as the proportion of participants who have a critical response (CR), partial response (PR) or disease stable (SD)

DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD).

Defined as the duration from the start of treatment until tumor progression or death of any cause

Maximum Plasma Concentration observed in patients with IMM2520 dosed

time to maximum concentration observed in patients with IMM2520 dosed

To evaluate the immunogenicity of IMM2520 in patients with malignancies

Shandong Cancer Hospital and Institute

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Melanoma

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

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Breast Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab will be given by intravenous infusion (IV, given by vein) at a dose of 200 mg, once every 3 weeks.

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Lillian Siu, M.D.

This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers in patients with solid tumors during treatment with pembrolizumab and in relation to response to treatment.

Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer cells.

This study will involve treatment with pembrolizumab, tests and procedures done for safety, and the collection of archival tumor tissue, fresh tumor biopsies, and blood samples for biomarker research (including genetic testing).

Study of the Effects of Pembrolizumab in Patients With Advanced Solid Tumors

Investigator-initiated Phase II Study of Pembrolizumab Immunological Response Evaluation

Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon rank sum tests may be substituted if necessary.

Positive predictive value and negative predictive value

Merck Sharp & Dohme LLC

University Health Network, Toronto

Digestive System Diseases

Blood and Lymph Conditions

Immune System Diseases

Mouth and Tooth Diseases

Heart and Blood Diseases

Stomach Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Lymphoma

Adenocarcinoma

Cholangiocarcinoma

Leukemia

Leukemia, Lymphoid

Carcinoma, Renal Cell

Liver Neoplasms

Carcinoma, Transitional Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Mouth Neoplasms

Kidney Neoplasms

Waldenstrom Macroglobulinemia

Lymphoma, Non-Hodgkin

Fallopian Tube Neoplasms

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Hematologic Diseases

Fallopian Tube Diseases

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Liver Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Lymphosarcoma

Bile Duct Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

Fallopian Tube Cancer

Oral Cancer

Laryngeal Cancer

Indolent B Cell Lymphoma

Lip and Oral Cavity Cancer

Hematinics

Gastrointestinal Agents

Amino Acids

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Liver Extracts

Pancrelipase

Pancreatin

Flt3 ligand protein

Tyrosine

Part 1: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance, or two years of treatment.

Part 2: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance or two years of treatment. A fixed dose of CDX-301 is injected once a day for five days before cycles 1 and 2 of CDX-1140.

Part 3: Eligible patients will receive CDX-1140, based on cohort assigned, in 3 week cycles until progression, or intolerance, or two years of treatment. A fixed dose of pembrolizumab will also be given in 3 week cycles.

Part 4: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, or intolerance, or two years of treatment. Chemotherapy will also be given according to standard of care.

CDX-1140 will be administered every 4 weeks in Parts 1, 2 and 4, and every 3 weeks in Part 3.

CDX-1140

CDX-301 will be injected once a day for five days before Cycles 1 and 2.

CDX-301

pembrolizumab will be administered every 3 weeks.

pembrolizumab

Gemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle.

Chemotherapy

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2), pembrolizumab (Part 3), or chemotherapy (Part 4) in patients with cancer.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-1140. The dose-escalation part of the study will test the safety profile of CDX-1140, alone or in combination with CDX-301, pembrolizumab or chemotherapy and determine which dose(s) of CDX-1140 will be studied in the expansion portions of the study.

All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies

The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.

The percentage of patients who achieved a confirmed complete response or partial response by evaluation criteria in solid tumors for immune-based therapeutics (iRECIST; for solid tumor patients) and the lymphoma response to immunomodulatory therapy criteria (LYRIC; for lymphoma patients).

The percentage of patients who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months

The interval from which measurement criteria are first met for CR or PR until the first date that progressive disease is objectively documented

The time from start of study drug to time of progression or death, whichever occurs first

The time from start of study drug to death

Serum samples will be obtained for assessment of human anti-CDX-1140 and anti-CDX-301 antibodies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IMM2520, a PD-L1 and CD47 Bispecific Antibody in Patients With Advanced Solid Tumors	NCT05780307	Advanced Solid ... Non-small Cell ... Small Cell Lung... Breast Cancer Squamous Cell C... Colorectal Canc...	IMM2520	18 Years -	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study of the Effects of Pembrolizumab in Patients With Advanced Solid Tumors	NCT02644369	Squamous Cell C... Triple Negative... Epithelial Ovar... Malignant Melan... Advanced Solid ...	Pembrolizumab	18 Years -	University Health Network, Toronto
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies	NCT03329950	Melanoma Non-small Cell ... Breast Cancer Gastric Cancer Renal Cell Carc... Ovarian Cancer Cholangiocarcin... Bladder Urothel... Pancreatic Aden... Colorectal Canc... Esophageal Canc... Hepatic Cancer Head and Neck C... Primary Periton... Fallopian Tube ... Other Solid Tum... Diffuse Large B... Mantle Cell Lym... Indolent B-cell... Non-Hodgkin Lym... Follicular Lymp... Lymphoplasmacyt... Waldenstrom's D... Marginal Zone L... Mucosa Associat... Small Lymphocyt...	CDX-1140 CDX-301 pembrolizumab Chemotherapy	18 Years -	Celldex Therapeutics
First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours	NCT04504669	Clear Cell Rena... Non-Small-Cell ... Triple Negative... Squamous Cell C... Small Cell Lung... Gastroesophagea... Melanoma Cervical Cancer Advanced Solid ...	AZD8701 Durvalumab	18 Years - 101 Years	AstraZeneca
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies	NCT03329950	Melanoma Non-small Cell ... Breast Cancer Gastric Cancer Renal Cell Carc... Ovarian Cancer Cholangiocarcin... Bladder Urothel... Pancreatic Aden... Colorectal Canc... Esophageal Canc... Hepatic Cancer Head and Neck C... Primary Periton... Fallopian Tube ... Other Solid Tum... Diffuse Large B... Mantle Cell Lym... Indolent B-cell... Non-Hodgkin Lym... Follicular Lymp... Lymphoplasmacyt... Waldenstrom's D... Marginal Zone L... Mucosa Associat... Small Lymphocyt...	CDX-1140 CDX-301 pembrolizumab Chemotherapy	18 Years -	Celldex Therapeutics
A Study of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer	NCT03246854	Head and Neck C... NSCLC	DBPR112	18 Years - 70 Years	National Health Research Institutes, Taiwan

Spots Global Cancer Trial Database for squamous cell cancer of head and neck