Clinical trials: Tissue Expansion, open to volunteers
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Gastrointestinal Stromal Tumors, Small-cell Lung Cancer
A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
This open-label clinical trial will evaluate the safety and tolerability of NN3201 in subjects with advanced and/or metastatic solid tumors known to express c-Kit.
- Conditions
- Gastrointestinal Stromal Tumors, Small-cell Lung Cancer, Adenoid Cystic Carcinoma, Uveal Melanoma
- Trial name
- NCT06805825
- Testing
- NN3201
- Where
- 5 sites in United States
- Volunteers
- 67 people
- Sponsor
- Novelty Nobility, Inc.
Solid Tumor, Melanoma
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Melanoma, HNSCC, Sarcoma
- Trial name
- NCT04370587
- Testing
- T3011, T3011 + pembrolizumab
- Where
- 9 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- ImmVira Pharma Co. Ltd
Advanced or Metastatic Breast Cancer
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with…
- Trial name
- NCT05187832
- Testing
- AND019 PO QD
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Kind Pharmaceuticals LLC
Cervical Cancer, Breast Cancer
Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or…
- Conditions
- Cervical Cancer, Breast Cancer, Colon Cancer, NSCLC
- Trial name
- NCT05283330
- Testing
- ²¹²Pb-DOTAM-GRPR1
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Orano Med Theranostics, SAS
Unspecified Adult Solid Tumor, Protocol Specific
Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI
A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of intravenous infusion of CP-506, a tumor agnostic Hypoxia Activated Prodrug in…
- Trial name
- NCT04954599
- Testing
- CP-506, Carboplatin, Immune checkpoint inhibitor
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 126 people
- Sponsor
- Maastricht University Medical Center
Advanced Solid Tumor, Metastatic Solid Tumor
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC)
- Trial name
- NCT05824975
- Testing
- GI-102 subcutaneous (SC), GI-102, doxorubicin
- Where
- 11 sites in United States, South Korea
- Volunteers
- 358 people
- Sponsor
- GI Innovation, Inc.
Tumor, Solid, Pancreatic Cancer
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.
- Conditions
- Tumor, Solid, Pancreatic Cancer, Melanoma
- Trial name
- NCT03454035
- Testing
- Ulixertinib, Palbociclib
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Solid Cancers, BRCA Mutation
A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway
The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced/metastatic solid tumors harboring BRCA1/2 loss of function…
- Conditions
- Solid Cancers, BRCA Mutation, HRD Cancer, Breast Cancer
- Trial name
- NCT06614751
- Testing
- DAT-2645 tablet
- Where
- 2 sites in China
- Volunteers
- 112 people
- Sponsor
- Danatlas Pharmaceuticals Co., Ltd
Small Cell Lung Cancer (SCLC), Large Cell Neuroendocrine Cancer (LCNEC)
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
This is a first-in-human, Phase 1/2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig…
- Conditions
- Small Cell Lung Cancer (SCLC), Large Cell Neuroendocrine Cancer (LCNEC), Neuroendocrine Prostate Cancer (NEPC), Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)
- Trial name
- NCT05652686
- Testing
- Peluntamig (PT217), Carboplatin + Etoposide, Paclitaxel.
- Where
- 15 sites in United States
- Volunteers
- 203 people
- Sponsor
- Phanes Therapeutics
Glioma, Recurrent High Grade, Grade 4 Malignant Glioma
A Study of NST-628 in Recurrent Grade 4 Glioma
This is an open-label, single arm, non-randomized, Phase 0 and expansion Phase 1 study of NST-628 in adult patients with recurrent Grade 4 glioma with high phosphorylated extracellular signal-regulated kinase (pERK) expression…
- Trial name
- NCT07784985
- Testing
- NST-628
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Nader Sanai
HER2-negative Breast Cancer, Metastatic Breast Cancer
CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at…
- Trial name
- NCT05029999
- Testing
- PLD Chemotherapy, CDX-1140, CDX-301
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Texas Southwestern Medical Center
Breast Cancer, Biliary Tract Carcinoma
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents
- Conditions
- Breast Cancer, Biliary Tract Carcinoma, Ovarian Cancer, Endometrial Cancer
- Trial name
- NCT05123482
- Testing
- AZD8205, AZD8205 and AZD2936 (Rilvegostomig), AZD8205 and AZD5305 (saruparib)
- Where
- 67 sites in United States, Australia and 13 more
- Volunteers
- 460 people
- Sponsor
- AstraZeneca
Breast Cancer
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human…
- Trial name
- NCT06515470
- Testing
- BTX-9341, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 82 people
- Sponsor
- Biotheryx, Inc.
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
Study of XB010 in Subjects With Solid Tumors
This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic…
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer, Head and Neck Squamous Cell Cancer, NSCLC (Non-small Cell Lung Cancer)
- Trial name
- NCT06545331
- Testing
- XB010, Pembrolizumab
- Where
- 20 sites in United States, United Kingdom
- Volunteers
- 396 people
- Sponsor
- Exelixis
Advanced Solid Tumor
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated…
- Trial name
- NCT04890613
- Testing
- CX-5461
- Where
- 8 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Senhwa Biosciences, Inc.
Advanced or Metastatic Solid Tumor
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab…
- Trial name
- NCT06270706
- Testing
- PLN-101095, Pembrolizumab
- Where
- 22 sites in United States, Spain
- Volunteers
- 124 people
- Sponsor
- Pliant Therapeutics, Inc.
Solid Tumours, Sarcoma
A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors
The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab. The overall objectives of this study are to determine the safety and tolerability (degree to which…
- Conditions
- Solid Tumours, Sarcoma, HNSCC, Non Small Cell Lung Cancer
- Trial name
- INVOKE (NCT06789172)
- Testing
- OKN4395, Pembrolizumab, Fasting
- Where
- 10 sites in United States, Australia and 1 more
- Volunteers
- 146 people
- Sponsor
- Epkin
Solid Tumor, Ovarian Cancer
A Phase I Study of XS-02 Capsules in Patients With Advanced Solid Tumors
A study to evaluate the safety, tolerability, pk, and efficacy of XS-02 capsules in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Ovarian Cancer, Breast Cancer, Endometrial Cancer
- Trial name
- NCT06531486
- Testing
- XS-02 capsules
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Ovarian Cancer, Breast Cancer
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced…
- Conditions
- Ovarian Cancer, Breast Cancer, Endometrial Cancer, Non-Small Cell Lung Cancer
- Trial name
- LNCB74-01 (NCT06774963)
- Testing
- LNCB74
- Where
- 17 sites in United States
- Volunteers
- 145 people
- Sponsor
- LigaChem Biosciences, Inc.