varsetatug masetecan (CX-2051) / CytomX, AbbVie - LARVOL DELTA

CytomX Therapeutics Announces FDA Fast Track Designation for Varsetatug masetecan ('Varseta-M') for Relapsed/Refractory Metastatic Colorectal Cancer (R/R mCRC) (GlobeNewswire) - "Fast Track Designation follows encouraging Phase 1 data that were previously reported for R/R mCRC; Potential Varseta-M monotherapy registrational study in R/R mCRC planned for initiation in 1H 2027."

Fast track • New trial • Colorectal Cancer

CytomX's Varsetatug Masetecan (Varseta-M) Receives FDA Fast Track Designation for Colorectal Cancer - "'Patients with late-stage metastatic CRC [colorectal cancer] face a poor prognosis and have very limited treatment options,' said Kimmie Ng, MD, MPH...'These exciting clinical data demonstrate that Varseta-M can drive consistent and durable responses with a manageable tolerability profile in patients with heavily pretreated CRC.'"

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Pipeline Program Updates: Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051) - Varseta-M CRC Combinations (GlobeNewswire) - "A Phase 1 combination study of Varseta-M and bevacizumab is ongoing in late-line patients with an initial focus on the evaluation of safety, dose, and schedule for later phase development. Initial clinical data is anticipated in 1H 2027. Additionally, a Phase 1/2 chemotherapy combination study including Varseta-M administered with bevacizumab, 5-fluorouracil, and leucovorin focused in 2nd line mCRC is planned to start in Q4 2026, supporting the goal of advancing Varseta-M into earlier lines of CRC treatment, potentially replacing chemotherapy in standard of care regimens."

New P1/2 trial • P1 data • Trial status • Colorectal Cancer

Pipeline Program Updates: Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051) - Varseta-M Non-CRC Indication Expansion (GlobeNewswire) - "Varseta-M monotherapy Phase 1 expansion cohorts are initiating in Q3 2026 in gastric and gastroesophageal junction (GEJ), EpCAM selected pancreatic ductal adenocarcinoma (PDAC), and EpCAM selected biliary tract cancer (BTC), an initial step towards realizing Varseta-M’s pan-tumor potential as a multi-indication antibody drug conjugate."

Trial status • Biliary Tract Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Ductal Adenocarcinoma

Pipeline Program Updates: Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051) - Varseta-M Monotherapy CRC (GlobeNewswire) - "Enrollment into the Varseta-M Phase 1 clinical study is complete with 113 total patients enrolled across the dose escalation, expansion, and optimization phases. As of the end of April 2026, enrollment in the dose optimization cohorts reached the goal of 40 patients across the 8.6 mg/kg Q3W and 10 mg/kg Q3W doses. A Phase 1 data update is expected by the end of 2026 with a focus on dose selection for late phase development. FDA interactions are planned towards alignment on the first monotherapy Varseta-M registrational study in CRC which the company aims to initiate in the first half of 2027."

FDA event • New trial • P1 data • Trial status • Colorectal Cancer

Pipeline Program Updates: Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051) (GlobeNewswire) - "Enrollment of 40 patients in Varseta-M Dose Optimization completed; data update expected in 2H 2026 to inform monotherapy dose selection and potential registrational trial in late line CRC; Varseta-M Phase 1 study evaluating combination with bevacizumab is ongoing with initial data expected by 1H 2027; Phase 1/2 Varseta-M chemotherapy combination study to be initiated in 2H 2026; Initiation of Phase 1 expansion cohort(s) in non-CRC indications planned for 2H 2026."

New P1/2 trial • P1 data • Trial status • Colorectal Cancer

Varsetatug Masetecan Exhibits Early Efficacy, Safety in Late-Line Colorectal Cancer (Targeted Oncology) - "'Patients with late-stage metastatic CRC face a poor prognosis and have very limited treatment options,' said Kimmie Ng, MD, MPH...in a news release.'These exciting clinical data demonstrate that Varseta-M can drive consistent and durable responses with a manageable tolerability profile in patients with heavily pretreated CRC, supporting its promise as a potential new treatment option for advanced CRC.'"

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CytomX’s Varsetatug Masetecan (EpCAM PROBODY ADC) Continues to Demonstrate Positive Data Supporting Potential as a New Treatment Option in Late-Line Colorectal Cancer (GlobeNewswire) - "The preliminary data are as of a January 16, 2026 data cutoff from the ongoing CTMX-2051-101 Phase 1 study...At the 8.6 mg/kg dose, the confirmed response rate was 20% with an estimated median PFS of 6.8 months and at the 10 mg/kg dose, the confirmed response rate was 32% with an estimated median PFS of 7.1 months; The disease control rate was 88% (49/56) across the expansion doses of 7.2 – 10 mg/kg; The doses of 8.6 mg/kg and 10 mg/kg have been prioritized for further evaluation with the goal of selecting a dose or doses for a registrational study...The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC."

FDA event • P1 data • Colorectal Cancer

Pipeline Program Updates (The Manila Times) - "Additional Phase 1 follow-up data are also expected to be presented at major medical meeting(s) in 2026...Phase 1b/2 study in combination with bevacizumab and chemotherapy is expected to start by the end of 2026....Initial clinical data for CX-801 in combination with KEYTRUDA in advanced melanoma is projected by the end of 2026."

New P1/2 trial • P1 data • Colorectal Cancer • Melanoma

Clinical Program Updates and 2026 Milestones: Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051) (CytomX Press Release) - "Total Phase 1 study enrollment is projected to reach approximately 100 patients by the planned Varseta-M Phase 1 update in Q1 2026. The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC. A Phase 1 Varseta-M combination study with bevacizumab in CRC is expected to start in Q1 2026, data from which is intended to inform potential late-phase development in earlier lines of CRC. Initiation of Phase 1 expansion cohort(s) in additional indications is planned for 2H 2026."

First-in-human • New P1 trial • Trial status • Colorectal Cancer

CX-2051 (EpCAM PROBODY Topo-1 ADC) (GlobeNewswire) - "CX-2051 Phase 1 dose expansions across the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) are ongoing. In Q3 2025, dose expansion enrollment continued with the goal of supporting a potential registrational study of CX-2051 monotherapy in advanced CRC. Phase 1 study enrollment is projected to reach approximately 100 patients by the planned CX-2051 Phase 1 update in Q1 2026."

P1 data • Trial status • Colorectal Cancer

A Phase 1b CX-2051 combination study with bevacizumab in CRC is expected to start in Q1 2026, data from which is intended to inform potential late-phase development in earlier lines of CRC therapy (GlobeNewswire)

New P1 trial • Colorectal Cancer

CytomX Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update (CytomX Press Release) - "CX-2051 (EpCAM PROBODY Topo-1 ADC): Phase 1 data update in advanced CRC in approximately 70 patients is expected by Q1 2026. Planning underway for CX-2051 Phase 2 study initiation in advanced, late-line CRC in 1H 2026. Potential to initiate CX-2051 combination studies in earlier lines of CRC therapy in 2026....CX-801 (PROBODY Interferon alpha-2b): Phase 1 dose escalation of CX-801 monotherapy continues. Preliminary tumor biomarker, pharmacodynamic (PD) and pharmacokinetic (PK) data evaluating the initial molecular performance of CX-801 monotherapy in the ongoing Phase 1 study are expected in the fourth quarter of 2025. In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Initial clinical data for the combination therapy in advanced melanoma is anticipated in 2026." "

New P2 trial • P1 data • Colorectal Cancer • Melanoma

CytomX Announces Positive Interim Data From Phase 1 Dose Escalation Study of EpCAM Antibody Drug Conjugate (CX-2051) Candidate in Patients with Advanced Colorectal Cancer (CRC) (GlobeNewswire) - P1 | N=124 | NCT06265688 | Sponsor: CytomX Therapeutics | "CytomX Therapeutics, Inc...announced positive interim Phase 1 data for its EpCAM PROBODY ADC candidate, CX-2051, in advanced, late-line CRC....Overall response rate (ORR): 28% of patients (5/18) achieved confirmed partial RECIST v. 1.1 responses. Overall response rates for currently approved therapies in 3rd line or later CRC are in the low to mid-single digit percentages. At the 10 mg/kg dose, 3 of 7 evaluable patients (43%) achieved confirmed partial responses. The Disease Control Rate was 94% across the three dose groups (17/18)....Dose expansions have been initiated at doses of 7.2 mg/kg, 8.6 mg/kg and 10 mg/kg Q3W. A total of 20 patients are expected to be enrolled at each dose level to inform the selection of recommended phase 2 dose."

P1 data • Trial status • Colorectal Cancer

CX-2051 Anticipated Milestones (GlobeNewswire) - "CX-2051 Monotherapy for Advanced Late-Line CRC: Additional Phase 1 data update by Q1 2026; Planning Phase 2 study initiation in 1H 2026. CX-2051 CRC Combinations: Potential to initiate CX-2051 combination studies in earlier lines of CRC in 2026. CX-2051 Pan-tumor Potential: Evaluate non-CRC, EpCAM-expressing tumor indications for potential Phase 1b study initiation in 2026."

New P1 trial • New P2 trial • New trial • P1 data • Colorectal Cancer

CytomX Therapeutics Announces 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Pipeline Program Updates: (i) CX-2051 (EpCAM PROBODY Topo-1 ADC)...The CX-2051 Phase 1 study is ongoing and is evaluating the seventh dose level. Initial Phase 1a data in CRC are expected to be presented in the first half of 2025....; (ii) CX-801 (PROBODY Interferon-alpha 2b):...The Phase 1 study is currently in the fourth monotherapy dose escalation cohort where the dose of CX-801 exceeds the approved dose of the unmasked peginterferon alfa-2b (SYLATRON). Initial Phase 1a translational and biomarker data in advanced melanoma is expected in the second half of 2025."

P1 data • Trial status • Melanoma • Solid Tumor

CytomX Therapeutics Announces 2025 Strategic Pipeline Priorities and Provides Corporate Update (GlobeNewswire) - "Clinical Program Updates and 2025 Milestones: CX-2051 (EpCAM PROBODY ADC):...The Phase 1 study of CX-2051 was initiated in April of 2024 and is focused in advanced metastatic CRC, one of many tumor types in which high expression of EpCAM has been documented....The CX-2051 study is currently in the sixth dose escalation cohort with patient enrollment to-date focused in advanced CRC patients who have generally received three or more prior lines of systemic therapy in the metastatic setting....In Phase 1 dose escalation to date, CX-2051 has demonstrated a favorable tolerability profile at dose levels predicted to be biologically active based on preclinical data. Initial Phase 1a data are expected in the first half 2025."

P1 data • Trial status • Colorectal Cancer

CytomX Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Third Quarter Business Highlights and Recent Developments:...(i) CX-2051:...The Phase 1 study of CX-2051 was initiated in Q2 2024 and is currently focused in metastatic colorectal cancer....The study is currently enrolling the fifth dose escalation cohort with favorable safety and tolerability having been observed to date. Initial Phase 1a data are expected in the first half 2025...; (ii) CX-801:...Phase 1 dose escalation is ongoing with a primary focus in melanoma. The study will evaluate safety and initial clinical activity for CX-801 monotherapy and for CX-801 in combination with KEYTRUDA. Initial Phase 1a data are expected in the second half of 2025."

P1 data • Trial status • Colorectal Cancer • Melanoma

CytomX Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities and Key Milestones: (i) CX-904 (EGFRxCD3): Continued Phase 1a dose escalation in PDAC, HNSCC and NSCLC focused on the selection of recommended Phase 1b dose(s); A CX-904 Phase 1 program update is expected by the end of 2024, including a potential decision to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types; (ii) CX-2051 (EpCAM): Continued Phase 1 dose escalation in solid tumors, primarily CRC; Initial Phase 1a data expected in the first half of 2025; (iii) CX-801 (IFNα2b): Continued Phase 1 dose escalation progress in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. Initial Phase 1a data expected in the second half of 2025."

P1 data • Trial status • Colorectal Cancer • Melanoma • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "In April 2024, the first patient was dosed as part of the Phase 1 dose escalation of CX-2051 in patients with solid tumors generally known to express EpCAM, including CRC. The first dose cohort in the CX-2051 Phase 1 study has been cleared and dose escalation continues. The Phase 1 dose escalation study is following a Bayesian Optimal Interval (BOIN) design....Initial data for CX-2051 is expected in the first half of 2025."

P1 data • Trial status • Colorectal Cancer

CTMX-2051-101: First In Human Study of CX-2051 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: CytomX Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

CytomX Therapeutics Announces First Patient Dosed with CX-2051, a Conditionally Activated EpCAM-Directed ADC, in a Phase 1 Study in Patients with Advanced Solid Tumors (GlobeNewswire) - "CytomX Therapeutics...announced the first patient has been dosed in a Phase 1 dose escalation study (NCT06265688) of CX-2051 in patients with advanced solid tumors....The cytotoxic payload utilized in CX-2051 is a derivative of camptothecin, a topoisomerase-1 inhibitor, a class of drug that has shown potent clinical anti-cancer activity and demonstrated significant clinical benefit as an approved ADC in multiple cancers. The CX-2051 Phase 1 dose escalation is designed to efficiently test the safety and preliminary anti-tumor activity of CX-2051, to provide initial clinical proof of concept to inform a potential decision to move into dose expansions in 2025."

Trial status • Solid Tumor

CytomX Therapeutics Reports 2023 Financial Results and Provides Business Update (GlobeNewswire) - "CX-2051 (EpCAM): Initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression, including locally advanced/metastatic colorectal cancer as a priority indication, is expected in the first half of 2024."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

First In Human Study of CX-2051 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Not yet recruiting | Sponsor: CytomX Therapeutics

Metastases • New P1 trial • Oncology • Solid Tumor

CytomX Therapeutics Announces FDA Clearance of IND Applications for CX-2051, a Probody Antibody Drug Conjugate (ADC) Targeting EpCAM and CX-801, a Conditionally Activated Interferon Alpha-2b (GlobeNewswire) - "CytomX Therapeutics...announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) applications for the conditionally activated Probody therapeutics CX-2051, an EpCAM-directed ADC, and CX-801, a dually-masked version of interferon-alpha 2b. CX-2051 has been cleared for the initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression and CX-801 has been cleared for the initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. Both programs are expected to start Phase 1 studies in the first half of 2024."

IND • New P1 trial • Melanoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck