Trials in Set-Up

A LIST OF OUR EARLY PHASE cancer trials currently in set-up AT UNIVERSITY COLLEGE LONDON HOSPITALS

Advanced Solid Tumours

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 (RET Inhibitor)
Patient Population:	Advanced Solid Tumours with RET-altered Malignancy

JEWEL-101 A DOSE-ESCALATION AND EXPANSION STUDY OF THE SAFETY AND PHARMACOKINETICS OF XB002 AS SINGLE-AGENT AND COMBINATION THERAPY IN SUBJECTS WITH INOPERABLE LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Local Project Reference:	TBC
Principal Investigator:	Dr Michael Flynn
Drug Class/Treatment:	XB002 (Antibody-Drug Conjugate)
Patient Population:	Inoperable Locally Advanced or Metastatic Solid Tumours

Breast

ELECTRA (ELA-0121) An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer (ELECTRA).
Local Project Reference:	TBC
Principal Investigator:	Dr Elisavet Papadimitraki
Drug Class/Treatment:	Elacestrant (oral selective estrogen receptor degrader) Monotherapy + In Combination Abemaciclib (Select CDK Inhibitor)
Patient Population:	Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Gynae-Oncology

SL03-OHD-105 An Open-Label, Phase 1b Study of SL-172154 (SIRPα-Fc-CD40L) Administered with Either Pegylated Liposomal Doxorubicin or Mirvetuximab Soravtansine in Subjects with Platinum-Resistant Ovarian Cancers
Local Project Reference:	TBC
Principal Investigator:	Dr Rowan Miller
Drug Class/Treatment:	SL-172154 (bi-functional fusion protein that targets CD47 on malignant cells and CD40 on immune cells) With Pegylated Liposomal Doxorubicin or Mirvetuximab Soravtasine
Patient Population:	Platinum-Resistant Ovarian Cancer

HAEMATOLOGY - LYMPHOMA & CLL

ASTX660-03 A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma
Local Project Reference:	TBC
Principal Investigator:	Dr William Townsend
Drug Class/Treatment:	ASTX660 (Tolinapant) (Dual Antagonist Inhibition of Apoptosis Proteins (IAPs) XIAP and cIAP) + ASTX727 (Oral Decitabine/Cedazuridine) (cytidine deaminase Inhibitor) And ASTX737 (Oral Decitabine/Cedazuridine) Alone
Patient Population:	Relapsed/Refractory Peripheral T-Cell Lymphoma

Haematology - Myeloma

BGI-11417-105 A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417 as Monotherapy, in Combination With Dexamethasone and Carfilzomib/Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)
Local Project Reference:	TBC
Principal Investigator:	Dr Rakesh Popat
Drug Class/Treatment:	BGB-11417 (BCL-2 Inhibitor) Monotherapy or Combination with Dexamethasone and Carfilzomib/Dexamethasone
Patient Population:	Relapsed/Refractory Multiple Myeloma and t(11;14)
Trial Hosted by - NIHR UCLH Clinical Research Facility (CRF)

CA057-003 An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants with Relapsed or Refractory Multiple Myeloma
Local Project Reference:	147900
Principal Investigator:	Dr Rakesh Popat
Drug Class/Treatment:	CC-92480 (Novel Cereblon E3 Ligase Modulator)
Patient Population:	Relapsed/Refractory Multiple Myeloma
Trial Hosted by - NIHR UCLH Clinical Research Facility (CRF)

CAMMA 1 - GO42552 AN OPEN-LABEL, MULTICENTER, PHASE Ib TRIAL EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF CEVOSTAMAB IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (CAMMA 1)
Local Project Reference:	146840
Principal Investigator:	Dr Rakesh Popat
Drug Class/Treatment:	Cevostamab (bispecific T-cell engager (BiTE) antibody)
Patient Population:	Relapsed/Refractory Multiple Myeloma
Trial Hosted by - NIHR UCLH Clinical Research Facility (CRF)

Lung

METalmark A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
Local Project Reference:	152527
Principal Investigator:	Dr Sarah Benafif
Drug Class/Treatment:	Amivantamab (EGFR and MET Receptor Bispecific Monoclonal Antibody) + Capmatinib (MET Receptor Tyrosine Kinase Inhibitor)
Patient Population:	Unresectable Metastatic Non-Small Cell Lung Cancer (NSCLC)

Urology

MK-3475 A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants with PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A
Local Project Reference:	137292
Principal Investigator:	Dr Anuradha Jayaram
Drug Class/Treatment:	Investigational Agents wirth or without Pembroliumab (PD-1 Inhibitor)
Patient Population:	PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma
Trial Hosted by - NIHR UCLH Clinical Research Facility (CRF)