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Solid Tumor, Adult clinical trials

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NCT ID: NCT06027346 Recruiting - Solid Tumor, Adult Clinical Trials

A Study of Bio-008 in Subjects With Advanced or Metastatic Solid Tumours

Start date: July 17, 2023
Phase: Phase 1
Study type: Interventional

Phase 1: Dose escalation study (Phase Ia) Main purpose: Evaluate the safety and tolerability of BIO-008 in patients with advanced solid tumors, and determine the maximum tolerable dose (MTD) and dose limiting toxicity (DLT) of BIO-008. Secondary purpose: Evaluate the pharmacokinetic (PK) characteristics of BIO-008; Evaluate the immunogenicity of BIO-008. Exploratory purposes: Preliminary evaluation of the anti-tumor activity of BIO-008 (if available); Detect the expression of CLDN18.2 in tumor tissue and explore its correlation with BIO-008 anti-tumor activity indicators (only applicable to subjects who can provide fresh or archived tumor tissue samples before the first administration). Phase 2: Dose Extension Study (Phase Ib) Main purpose: • Preliminary evaluation of ORR of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer (GC/GEJ), pancreatic cancer (PC) and other solid tumors; Determine the recommended dose for clinical phase II (RP2D). Secondary purpose: Evaluate the safety and tolerability of BIO-008; Evaluate the PK characteristics of BIO-008; Evaluate the immunogenicity of BIO-008; • Evaluate other anti-tumor activity indicators of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer, pancreatic cancer and other solid tumors; Evaluate the correlation between the anti-tumor activity of BIO-008 and the expression of CLDN18.2.

NCT ID: NCT06003621 Recruiting - Solid Tumor, Adult Clinical Trials

Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients

MoST-TAP
Start date: December 15, 2023
Phase: Phase 2
Study type: Interventional

This phase II study will explore the effect of 2 monoclonal antibodies, tiragolumab and atezolizumab, in patients with locally advanced solid cancers which cannot be removed by surgery or have spread. Their cancers will have characteristics which may predict immune response to the study treatment. PD-L1 and TIGIT are immune receptors which can help cancers grow by evading the immune response and inhibiting the action of some immune cells. By blocking these receptors, tiragolumab and atezolizumab may work together to re-activate the body's anti-tumour immune response and kill cancer cells.

NCT ID: NCT05958121 Recruiting - Cancer Clinical Trials

IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

Start date: August 9, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors. Primary objectives: - To determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I) - To characterize the safety and tolerability of IMA402 (Phase I/II) - To evaluate anti-tumor activity of IMA402 (Phase II) Secondary objectives: - To evaluate the initial anti-tumor activity of IMA402 (Phase I) - To evaluate anti-tumor activity of IMA402 (Phase II) - To describe the PK of IMA402 (Phase I/II)

NCT ID: NCT05947695 Recruiting - Solid Tumor, Adult Clinical Trials

Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

The purpose of the randomized control trial is to estimate the effect of an oncology clinical nurse specialist-led early intervention multidisciplinary approach to palliative and survivorship care within two previously identified and validated patient groups having metastatic solid tumor malignancy on patient-reported symptom burden, patient-reported overall quality of life (QOL), distress, and overall survival. The primary hypothesis is that the effect of an oncology clinical nurse specialist- led early intervention multidisciplinary palliative and survivorship care model will be significantly higher, as compared to the standard of care approach to palliative and survivorship care, on the primary endpoint of patient-reported symptom burden for patients with metastatic solid tumor malignancy within favorable and very favorable risk groups. Symptom burden includes pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing.

NCT ID: NCT05947487 Recruiting - Solid Tumor, Adult Clinical Trials

CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors

Start date: July 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive advanced/metastatic solid tumors . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).

NCT ID: NCT05888532 Recruiting - Prostate Cancer Clinical Trials

64Cu-GRIP B in Patients With Advanced Malignancies

Start date: May 25, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II clinical trial evaluates if using a radiotracer targeting granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64 Cu-GRIP B) with positron emission tomography (PET) imaging can be safe and useful for detecting granzyme B (GrB) in patients with advanced cancers that has spread to nearby tissue or lymph nodes (advanced). Granzyme B (GrB) is a biomarker produced by immune cells in response to immunotherapy, which may highlight tumors that are more likely to respond to treatment. The study population is focused on genitourinary (GU) malignancies, including renal cell and urothelial cancer, two tumor types with high mutational burden and tumor infiltrating lymphocytes compared to other tumor types, and have a predictable response rate at the population level to immune checkpoint inhibitors. The information gained from this trial may allow researchers to develop future trials where 64Cu-GRIP B PET may serve as a biomarker to monitor early response to immunomodulatory therapies which are used to stimulate or suppress the immune system and may help the body fight cancer.

NCT ID: NCT05868226 Recruiting - Solid Tumor Clinical Trials

PRE-I-SPY Phase I/Ib Oncology Platform Program

PRE-I-SPY-PI
Start date: December 22, 2022
Phase: Phase 1
Study type: Interventional

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

NCT ID: NCT05868174 Recruiting - Clinical trials for Advanced Solid Tumor

Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors

Start date: May 23, 2023
Phase: Phase 1
Study type: Interventional

This is an open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors.

NCT ID: NCT05866692 Recruiting - Solid Tumor, Adult Clinical Trials

A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors

Start date: August 17, 2023
Phase: Phase 1
Study type: Interventional

This is a phase I, multicenter, open-label study. The study will investigate the safety, tolerability, PK, and preliminary efficacy of TY-2699a on locally advanced or metastatic solid tumors.

NCT ID: NCT05865990 Recruiting - Clinical trials for Metastatic Breast Cancer

HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease

TUXEDO-3
Start date: November 24, 2023
Phase: Phase 2
Study type: Interventional

The goal of this phase II clinical trial] is to analyze the efficacy of patritumab deruxtecan (HER3-DXd) in patients with metastatic breast cancer (MBC) or advanced non-small cell lung cancer (aNSCLC) with active brain metastases (BM) who have received at least one line of systemic therapy in the advanced setting, or patients with active leptomeningeal carcinomatosis/disease (LMD) after radiotherapy from an advanced solid tumor who do not need immediate local treatment, and have not received prior treatment with an anti-HER3 targeted drug]. The main questions it aims to answer are: - The intracranial objective response rate (ORR-IC) per local investigator as judged by best central nervous system (CNS) response according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria of HER3-DXd in patients with active BM from MBC (Cohort 1) and aNSCLC (Cohort 2). - The overall survival (OS) rate at 3 months of HER3-DXd in patients with advanced solid tumors with untreated LMD (Cohort 3). Participants will receive HER3-DXd on day (D1) of each 21-day cycle until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Researchers will compare historical groups to see if HER3-DXd positively impacts patient outcomes.