Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

Conditions

• Advanced Solid Tumors
• Colorectal Cancer
• Gastroesophageal Adenocarcinoma
• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ABBV-400 — DRUG
  Intravenous (IV) Infusion
• Trifluridine/Tipiracil — DRUG
  Oral Tablet
• Bevacizumab — DRUG
  IV Infusion

Study Details

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) \[Part 2i\] or mutated EGFR-expression (mutEGFR NSCLC) \[Part 2ii\], squamous NSCLC \[Part 2iii\], GEA \[Part 3\] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion \[Part 4\], participants MET amplification will receive IV ABBV-400 monotherapy in expansion \[Part 5\], participants MET mutation will receive IV ABBV-400 monotherapy in expansion \[Part 6\], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab \[Part 7a\], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets \[Part 7b\]. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Key Dates

Start date

Oct 13, 2021

Status verified

Oct 2025

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

520 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 (Monotherapy Dose Escalation)
  Participants with advanced solid tumors will receive escalating doses of ABBV-400.
• Experimental: Part 2i (wtEGFR Non-Small Cell Lung Cancer [NSCLC])
  Participants with non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).
• Experimental: Part 2ii (mutEGFR NSCLC)
  Participants with non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D.
• Experimental: Part 2iii (Squamous NSCLC)
  Participants with squamous NSCLC will receive ABBV-400 at RP2D.
• Experimental: Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel Junct
  Participants with gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D.
• Experimental: Part 4 (Colorectal Cancer)
  Participants with Colorectal Cancer (CRC) will receive ABBV-400 at the RP2D and various dose levels for dose optimization.
• Experimental: Part 5 (MET Amplification)
  Participants with mesenchymal-epithelial transition proto-oncogene (MET) amplification will receive ABBV-400 at the RP2D and various dose levels for dose optimization.
• Experimental: Part 6 (MET Mutation)
  Participants with MET mutation will receive ABBV-400 at the RP2D and various dose levels for dose optimization.
• Experimental: Part 7a (Combination Dose Escalation)
  Participants with CRC will receive escalating doses of ABBV-400 in combination with bevacizumab.
• Experimental: Part 7bi (Combination Dose Optimization Low Dose)
  Participants with CRC will receive the low dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.
• Experimental: Part 7bii (Combination Dose Optimization High Dose)
  Participants with CRC will receive the high dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.
• Experimental: Part 7biii (Combination Comparator)
  Participants with CRC will receive trifluridine/tipiracil (TAS-102) in combination with bevacizumab.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 48 Months ]

Locations (18)

Find similar trials in Los Angeles, CA

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