Advanced Solid Tumour Trials

A list of our early phase Advanced solid tumour & basket study trials which are open to recruitment at University College London Hospitals

To find more information on UCLH CRF Early Phase Cancer Clinical Trials, including eligibility criteria, click the hyperlinked Local Project Reference (LRP) ID, which will take you to the UCLH Find a Study database.

GO42144 A Phase I/IIa, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD7648 Monotherapy or in Combination with either Cytotoxic Chemotherapies or Novel Anti-Cancer Agents in Patients with Advanced Malignancies
Local Project Reference:	140092
Principal Investigator:	Dr. Martin Forster
Drug Class/ Treatment:	AZD7648 (KRAS G12C Inhibitor) Monotherapy and Combination with Anti-Cancer Therapies
Patient Population:	Advanced or Metastatic Solid Tumours with KRAS G12c Mutation
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

IMC-F106C-101 A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers
Local Project Reference:	130728
Principal Investigator:	Dr. Heather Shaw
Drug Class/ Treatment:	IMC-F106C (Bispecific Antibody against HLA-A*02:01)
Patient Population:	HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

GARNET A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors.
Local Project Reference:	16/0355
Principal Investigator:	Dr. Rowan Miller
Drug Class/ Treatment:	TSR-042 (Dorstarlimab) (Anti PD-L1 Monoclonal Antibody)
Patient Population:	Advanced Solid Tumours Cohort F - Patients with Recurrent or Advanced Non-endometrial and non-GI dMMR/MSI-H Solid Tumours or POLE-Mut Cancers
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

NX-1607-101 A Phase 1a Dose Escalation Safety and Tolerability Study of NX-1607 a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor in Adults with Advanced Malignancies with Phase 1b Expansion in Select Tumor Types: A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor, in Adults with Advanced Malignancies, with Phase 1b Expansion in Select Tumor Types
Local Project Reference:	140364
Principal Investigator:	Prof. Daniel Hochhauser
Drug Class/ Treatment:	NX-1607 - CBL-B Inhibitor
Patient Population:	Advanced Malignancies
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

TAPISTRY (BO41932) TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL
Local Project Reference:	138000
Principal Investigator:	Dr. Martin Forster
Drug Class/ Treatment:	Cohort A: Entrectinib - TKI of TRK and ROS1 Cohort B: Entrectinib - TKI of TRK and ROS1 Cohort C: Alectinib - ALK Inhibitor Cohort H: GDC-0077 (RO7113755) - PI3K Inhibitor Cohort K: Pralsetinib - RET Inhibitor
Patient Population:	Solid Tumours: Cohort A - ROS1 fusion-positive tumors Cohort B - NTRK1/2/3 fusion-positive tumors Cohort C - ALK Fusion-Positive Tumours Cohort H - PIK3CA-mutant tumors Cohort K - RET fusion-positive tumors
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

MODI-1-001 Modi-1 in Patients with Breast, Head & Neck, Ovarian or Renal Cancer: A Phase 1/2, Multicentre, Open-Label Study of Modi-1 in Patients with Breast, Head and Neck, Ovarian, or Renal Cancer
Local Project Reference:	142749
Principal Investigator:	Dr. Rowan Miller
Drug Class/ Treatment:	Modi-1 - Novel Cancer Vaccine
Patient Population:	Advanced Solid Tumours: HPV-Negative Squamous Cell Carcinoma of the Head & Neck (oral cavity, oropharynx, hypopharynx, or larynx). Renal Cell Carcinoma.
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

Immunophotonics ZZA55720 Intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors. A multicenter Phase 1b/2a trial in colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients
Local Project Reference:	148701
Principal Investigator:	Dr Steve Bandula
Drug Class/Treatment:	IP-001 (inCVAX - cancer vaccine) Intratumoral Injection folllowing Thermal Ablation
Patient Population:	Advanced Solid Tumours Colorectal Cancer Non-Small Cell Lung Cancer Soft Tissuer Sarcoma
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

PARPA-293-001 Dose Escalation Study of NMS-03305293 in Patients with Selected Advanced/Metastatic Solid Tumours: A Phase I Dose Escalation Study of NMS-03305293 in Adult Patients with Selected Advanced/Metastatic Solid Tumors
Local Project Reference:	155266
Principal Investigator:	Dr Michael Flynn
Drug Class/Treatment:	NMS-03305293 (PARP Inhibitor) Dose Expansion Cohorts
Patient Population:	Advanced Solid Tumours: Schedule B Arm - Dose Expansion HER2 negative breast cancer pre-treated with PARP inhibitors HER2 negative breast cancer not pre-treated with PARP inhibitors CRPC (pre-treated and not pre-treated with PARP inhibitors)
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

TAK-676-1002 An Open-label, Dose Escalation, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors
Local Project Reference:	153491
Principal Investigator:	Dr Martin Forster
Drug Class/ Treatment:	TAK-676 (Novel Stimulator of Interferon Genes (STING) Single Agent and in Combination with Pembrolizumab
Patient Population:	Advanced Solid Tumours: Part 2A - Squamous Cell Carcinoma of the Head & Neck (SCCHN) Part 3A - MSI-H/dMMR Colorectal Cancer
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

EP0031-101 A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies
Local Project Reference:	151414
Principal Investigator:	Dr Martin Forster
Drug Class/ Treatment:	EP0031-101 (Selective RET Inhibitor)
Patient Population:	Advanced RET-Altered Malignancies • Cohort 5 - Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC) with RET • Cohort 6 - Locally Advanced or Metastatic Solid Tumours with RET-altered genes
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

Mobilize (mRNA-4359-P101) Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants with Advanced Solid Tumors
Local Project Reference:	158203
Principal Investigator:	Dr Martin Forster
Drug Class/ Treatment:	mRNA-4359-P101 (Checkpoint mRNA cancer vaccine) Combination with Checkpoint Inhibitors: · Arm 1b - Combination with Pembrolizumab
Patient Population:	Advanced Solid Tumours: Arm 1b - Melanoma and NSCLC
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

NVG111-101 NVG111-101: An open-label, phase 1/2, first in human study investigating the safety, tolerability, pharmacokinetics and efficacy of NVG-111 in subjects with relapsed/refractory chronic lymphocytic leukaemia and mantle cell lymphoma.
Local Project Reference:	135715
Principal Investigator:	Dr William Townsend
Drug Class/ Treatment:	NVG-111 (Receptor Tyrosine Kinase Like Orphan Like Receptor 1 (ROR1) Bispecific Antibody)
Patient Population:	Advanced Solid Tumours (Myeloma and NSCLC)
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

GCT1047-01 First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors
Local Project Reference:	157969
Principal Investigator:	Dr Michael Flynn
Drug Class/ Treatment:	GEN1047 (DuoBody®-CD3×B7H4 Bispecific Antibody)
Patient Population:	Advanced Solid Tumours: Endometricla Cancer Platinum-Resistant Ovarian Cancer (PROC) Triple-Negative Breast Cancer (TNBC)
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

Mobilize (mRNA-4359-P101) Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants with Advanced Solid Tumors
Local Project Reference:	158203
Principal Investigator:	Dr Martin Forster
Drug Class/ Treatment:	mRNA-4349 + Pembrolizumab Dose Confirmation
Patient Population:	Arm 1 B: Checkpoint Inhibitor Refractgory Melanoma Checkpoint Inhibitor Refracgtory NSCLC
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

GTAEXS617-001 A Phase 1/2 open-label multicenter study to assess the safety, pharmacokinetics, and anti-tumor activity of GTAEXS617 in patients with advanced solid tumors
Local Project Reference:	155196
Principal Investigator:	Dr Martin Forster
Drug Class/ Treatment:	GTAEXS617 (Selective CDK7 Inhibitor) Dose Escalation
Patient Population:	Advanced Solid Tumours
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

XB002-101 (JEWEL-101) A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Local Project Reference:	153449
Principal Investigator:	Dr Michael Flynn
Drug Class/ Treatment:	XB002 (Tissue factor (TF)–targeted antibody-drug conjugate)
Patient Population:	Advanced Solid Tumours
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

ROLo ROLo: Phase II study of ROS1 targeting with crizotinib in advanced E-cadherin negative, ER positive lobular breast cancer or diffuse gastric cancer
Local Project Reference:	18/0518
Principal Investigator:	Dr. Rebecca Roylance
Drug Class/ Treatment:	Crizotinib (ROS1 Inhibitor) + Fulvestrant (Hormone Injections)
Patient Population:	Advanced E-Cadherin Negative ER Positive Lobular Breast Cancer Diffuse Gastric Cancer
Trial Hosted By - UCLH Cancer Clinical Trials Unit (CCTU)

DETERMINE An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers with Actionable Genomic Alterations, including Common Cancers with Rare Actionable Alterations
Local Project Reference:	150307
Principal Investigator:	Dr Martin Forster
Drug Class/ Treatment:	A - Alectinib (ALK Inhibitor) B - Atezolizumab (IgG1 Monoclonal antibody targeting PD-L1) C - Entrectinib (ROS1 & TRK Inhibitor) D - Trastuzumab (HER2 Monoclonal Antibody) + Pertuzumab (HER2 Dimerization Inhibitor) E - Vemurafenib (B-RAF enzyme Inhibitor)
Patient Population:	Adult, Paediatric and Teenage/Young Adult (TYA) Cancers with Actionable Genomic Alterations: A - Adult, Teenage/Young Adults and Paediatric patients with ALK positive cancers. B - Adult, Teenage/Young adults and Paediatric patients with cancers with high tumour mutational burden (TMB) or microsatellite instability-high (MSI-high) or proven constitutional mismatch repair deficiency (CMMRD) disposition. C - Adult, Teenage/Young Adult and Paediatric patients with C-Ros Oncogene 1 (ROS1) gene fusion positive cancers (Not NSCLC). D - Adult, Teenage/Young Adult and Paediatric patients with cancers with HER2 amplification or mutations. E - Adult patients
Trial Hosted By - UCLH Cancer Clinical Trials Unit (CCTU)

Trials on-hold to recruitment

OVM-200-100 First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine: A Phase 1, Multicenter, Open-label, Nonrandomized, First-in-human Study of OVM-200 as a Therapeutic Vaccine in Patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer, Ovarian Cancer, and Prostate Cancer
Local Project Reference:	138608
Principal Investigator:	Dr. Martin Forster
Drug Class/ Treatment:	OVM-200 (Cancer Vaccine)
Patient Population:	Locally Advanced or Metastatic: Non-Small Cell Lung Cancer Ovarian Cancer Prostate Cancer
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

Principal Investigator(s):

Dr. martin forster

Associate Professor & Consultant Medical Oncologist

UCL ECMC Clinical Lead

dr. rowan miller

Consultant Medical Oncologist

dr. Dionysis Papadatos-Pastos

Consultant Medical Oncologist

Dr. michael Flynn

Consultant Medical Oncologist

Dr. sarah benafif

Consultant Medical Oncologist

Dr. heather shaw

Consultant Medical Oncologist

Dr. Elisavet (Elsa) Papadimitraki

Consultant Medical Oncologist

Dr. rebecca roylance

Consultant Medical Oncologist