giloralimab (ABBV-927) / AbbVie - LARVOL DELTA

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=163 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Mar 2026 ➔ Sep 2026 | Trial primary completion date: Mar 2026 ➔ Sep 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=163 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Sep 2025 ➔ Mar 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis (clinicaltrials.gov) - P1 | N=40 | Terminated | Sponsor: AbbVie | Phase classification: P1/2 ➔ P1

Phase classification • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=163 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2025

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis (clinicaltrials.gov) - P1/2 | N=40 | Terminated | Sponsor: AbbVie | Completed ➔ Terminated; Strategic considerations

Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Sep 2024 ➔ Mar 2025 | Trial primary completion date: Sep 2024 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=163 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Nov 2023 ➔ Sep 2024 | Trial primary completion date: Nov 2023 ➔ Sep 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed | Phase classification: P1b/2 ➔ P1/2

Adverse events • Combination therapy • Metastases • Phase classification • Trial completion • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis (clinicaltrials.gov) - P1b/2 | N=40 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=129 ➔ 40 | Trial completion date: Dec 2024 ➔ Mar 2024 | Trial primary completion date: Dec 2024 ➔ Mar 2024

Adverse events • Combination therapy • Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis (clinicaltrials.gov) - P1b/2 | N=129 | Recruiting | Sponsor: AbbVie | Trial completion date: Jun 2025 ➔ Dec 2024 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Adverse events • Combination therapy • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=163 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Oct 2022 ➔ Feb 2024 | Trial primary completion date: Oct 2022 ➔ Feb 2024

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Phase 1b/2 study of giloralimab in combination with modified FOLFIRINOX with or without budigalimab in patients with untreated metastatic pancreatic cancer (AACR 2022) - P1b/2 | "Combination therapy with modified FOLFIRINOX (leucovorin, irinotecan, 5-fluorouracil, and oxaliplatin) and immunotherapy has been proposed for first-line metastatic pancreatic cancer to improve tolerability and clinical efficacy, respectively (NCCN, Pancreatic. Approximately 129 patients are planned to be included. Enrollment started in June 2021, with 7 patients enrolled as of November 2021."

Clinical • Combination therapy • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD40

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: AbbVie | Trial completion date: Jul 2024 ➔ Nov 2023

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: AbbVie | Trial completion date: Dec 2023 ➔ Jul 2024

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=163 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: May 2022 ➔ Oct 2022 | Trial primary completion date: Feb 2022 ➔ Oct 2022

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=180; Active, not recruiting; Sponsor: AbbVie; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] A phase I study of CD40 agonist ABBV-927 plus OX40 agonist ABBV-368 with or without the PD-1 inhibitor budigalimab in patients with advanced solid tumors. (ASCO 2020) - P1 | "Screening began on 21 May 2019, and enrollment is ongoing. Research Funding: Abbvie, Inc"

Clinical • P1 data • Breast Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer • CD40 • TNFRSF4

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=180; Recruiting; Sponsor: AbbVie; Trial completion date: Nov 2021 ➔ Apr 2022; Trial primary completion date: Nov 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinoma Estudio que evalúa la seguridad y eficacia de ABBV-927 administrado en combinación con FOLFIRINOX modificado (mFFX) con o sin budigalimab en comparación con mFFX e (clinicaltrialsregister.eu) - P1/2; N=129; Ongoing; Sponsor: AbbVie Deutschland GmbH & Co. KG

New P1/2 trial • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

Current status of intralesional agents in treatment of malignant melanoma. (PubMed, Ann Transl Med) - "This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid..."

Journal • Review • Gene Therapies • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • CD40 • IL12A • MAGEA3 • TYRP1

Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis (clinicaltrials.gov) - P1b/2; N=129; Recruiting; Sponsor: AbbVie; Trial completion date: Aug 2024 ➔ Jun 2025

Adverse events • Clinical • Combination therapy • Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor