revdofilimab (ABBV-368) / 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 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

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 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

Selection and in vitro characterization of ABBV-368, a novel anti-OX40 agonist antibody (SITC 2019) - P1, P1b; "ABBV-368 is an anti-OX40 agonist with unique signaling activity that is efficacious in human cell in vitro and in vivo models and represents a promising clinical candidate currently being evaluated in several ongoing Phase I clinical trials (NCT03071757; NCT03893955; NCT03818542)."

Preclinical • Oncology • BCL2 • BCL2L1 • BIRC5 • IFNG

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 to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1b | N=30 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • 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 | 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 the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=139 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1b | N=30 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=69 ➔ 30

Enrollment change • Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=170 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Sep 2021 ➔ Feb 2022 | Trial primary completion date: Sep 2021 ➔ Feb 2022

Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1b; N=69; Recruiting; Sponsor: AbbVie; Trial primary completion date: May 2022 ➔ Nov 2022

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

[VIRTUAL] Phase Ib trial of ABBV-368 + tilsotolimod in combination with nab-paclitaxel and/or budigalimab (ABBV-181) in patients with recurrent/metastatic head and neck squamous cell carcinoma (ESMO 2020) - P1b | "funded this study. Clinical trial identification: NCT04196283."

Clinical • Combination therapy • P1 data • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A phase 1 dose-escalation study of safety, tolerability, and pharmacokinetics (PK) of ABBV-368 monotherapy and combination in patients (pts) with locally advanced or metastatic solid tumors (SITC 2019) - P1; "For CE2, the primary endpoints are safety, tolerability, and PK of ABBV-368 monotherapy and in combination with ABBV-181 (a humanized anti-programmed cell death 1 monoclonal antibody), and to establish the recommended phase 2 dose; the secondary endpoint is preliminary antitumor activity of ABBV-368 monotherapy and combination therapy. N/A"

Clinical • Monotherapy • P1 data • PK/PD data

[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

Safety, Tolerability, and Pharmacokinetics of the OX40 Agonist ABBV-368 in Patients With Advanced Solid Tumors (ESMO 2018) - P1; "ABBV-368 was well tolerated; a maximum tolerated dose was not reached. Antitumor activity was observed at doses predicted to be biologically active. Further evaluation of ABBV-368 is ongoing in pts with advanced solid tumors."

Clinical • IO biomarker • PK/PD data • Solid Tumor

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1b; N=69; Recruiting; Sponsor: AbbVie; Trial primary completion date: Nov 2022 ➔ May 2022

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

[VIRTUAL] Development of a workflow to handle the quality control and analysis of Olink protein biomarker data in early phase oncology clinical trials (AACR 2021) - "We have developed a comprehensive workflow that manages Olink quality control and analysis and can potentially be implemented to all early-phase oncology clinical trials using Olink. It allows us to standardize and streamline Olink data handling and provide robust and efficient analyses that enable rapid biomarker data interpretation, hypothesis generation, and decision making for our trials."

Biomarker • Clinical • Oncology

Idera Pharmaceuticals to Present Tilsotolimod Data at ESMO Virtual Congress 2020 (GlobeNewswire) - "Idera Pharmaceuticals, Inc...announced that final data from the ILLUMINATE-204 trial investigating intratumoral tilsotolimod, Idera's investigational Toll-like receptor 9 (TLR9) agonist, will be presented in a Mini Oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, to be held September 19-21, 2020. In addition, final results from ILLUMINATE-101 will be shared in a poster presentation....Adi Diab...will be delivering the mini-oral presentation as part of the mini oral session on melanoma and other skin tumors."

Clinical data • P1 data • P1/2 data • P3 data • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

ABBV-368 + tilsotolimod: Proof-of-concept data from P1b (NCT04196283) trial for recurrent/metastatic HNSCC in 2021 (AbbVie, 39th Annual J.P. Morgan Healthcare Conference (Virtual Meeting))

P1 data • Oncology • Squamous Cell Carcinoma of Head and Neck

ABBV-368 + tilsotolimod: Proof-of-concept data from P1b (NCT04196283) trial for recurrent/metastatic HNSCC in 2021 (AbbVie, 39th Annual J.P. Morgan Healthcare Conference (Virtual Meeting))

P1 data • Oncology • Squamous Cell Carcinoma of Head and Neck

A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1b; N=3; Terminated; Sponsor: AbbVie; Trial completion date: Jan 2021 ➔ Sep 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Jan 2021 ➔ Sep 2020; Strategic considerations

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

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1b; N=69; Recruiting; Sponsor: AbbVie; Trial completion date: May 2022 ➔ Nov 2022; Trial primary completion date: May 2022 ➔ Nov 2022

Clinical • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • 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; Recruiting; Sponsor: AbbVie; Trial primary completion date: May 2023 ➔ Nov 2023

Clinical • 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

A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1b; N=104; Recruiting; Sponsor: AbbVie; Trial primary completion date: Mar 2021 ➔ Oct 2021

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