Lung Cancer Clinical Trial

A Phase 1 Study With ABBV-CLS-484 in Subjects With Locally Advanced or Metastatic Tumors

Summary

The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).

The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).

Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.

Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors.

Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must weigh at least 35 kilograms (kg).
An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Life expectancy of ≥ 12 weeks.
Laboratory values meeting protocol criteria.
QT interval corrected for heart rate < 470 msec (using Fridericia's correction), and no clinically significant electrocardiographic findings.
Measurable disease defined by RECIST 1.1 criteria.

For Monotherapy and Combination Dose Escalation:

• Subjects with histologically or cytologically proven metastatic or locally advanced tumors, for which no effective standard therapy exists, or where standard therapy has failed. Subjects must have received at least 1 prior systemic anticancer therapy for the indication being considered.

For Monotherapy Dose Expansion only:

Subjects must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy with a best response by RECIST v1.1 of CR/PR/stable (any duration) or stable disease (for greater than 6 months); AND

Must have been previously treated with 1 or more prior lines of therapy in the locally advanced or metastatic setting with the following tumor types:

Relapsed/refractory HNSCC
Relapsed/refractory NSCLC
Advanced ccRCC

For PD-1 Targeting Agent Combination Dose Expansion only:

For the following tumor types, subject must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy with response by RECIST v1.1 of CR/PR (any duration) or stable disease (for greater than 6 months):
Relapsed HNSCC
Relapsed NSCLC
Relapsed Advanced ccRCC
For the following tumor types, subject must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy and have had disease progression with PD-1/PD-L1 targeted therapy:
Locally Advanced or metastatic MSI-H tumors

For VEGFR TKI Combination Dose Expansion only:

Relapsed advance ccRCC with no more than 1 prior VEGFR TKI
Subjects no recent history of hemorrhage, including hemoptysis, hematemesis, or melena
Subjects with poorly controlled hypertension are excluded

Exclusion Criteria:

Untreated brain or meningeal metastases (i.e., subjects with history of metastases are eligible provided they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 28 days after definitive therapy)
Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
Unresolved Grade 2 or higher peripheral neuropathy.
History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
Recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis, or clinically significant pericardial effusion or arrythmia.
Recent history (within 6 months) of Childs-Pugh B or C classification of liver disease.
History of clinically significant medical and/or psychiatric conditions or any other reason that, in the opinion of the investigator, would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
History of uncontrolled, clinically significant endocrinopathy.
Known gastrointestinal disorders making absorption of oral medications problematic; subject must be able to swallow capsules.
If treated with a PD-1/aPD-L1 targeting or other immune-oncology agents in the past, excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation.
Active autoimmune disease requiring systemic treatment in past 2-years (exceptions for endocrinopathies, vitiligo or atopic conditions).
History of solid organ transplant or allogeneic stem cell transplant.

History of other malignancy, with the following exceptions:

No known active disease present within ≥ 3 years before first dose of study treatment and felt to be at low recurrence by investigator.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease.
History of interstitial lung disease or pneumonitis.
Major surgery ≤ 28 days prior to first dose of study drug
Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

248

Study ID:

NCT04777994

Recruitment Status:

Recruiting

Sponsor:

Calico Life Sciences LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 17 Locations for this study

See Locations Near You

Yale University
New Haven Connecticut, 06519, United States More Info
Cynthia Palmeri
Contact
203-361-4367
Patricia LoRusso
Principal Investigator
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States More Info
David McDermott
Contact
617-667-7000
David F McDermott
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Contact
617-632-3090
Kartik Sehgal
Principal Investigator
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor Michigan, 48109, United States More Info
Laura Hurley
Contact
734-647-8902
Ulka N Vaishampayan
Principal Investigator
Carolina BioOncology Institute
Huntersville North Carolina, 28078, United States More Info
Lindsay Davis
Contact
704-947-6599
John Powderly
Principal Investigator
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Vivian Leung
Contact
215-662-7911
Lova Sun
Principal Investigator
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Sarah Behr
Contact
412-623-6028
Jason Luke
Principal Investigator
Lifespan Cancer Institute at Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Victoria Nelson
Contact
401-444-6217
Benedito Carneiro
Principal Investigator
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Nasir Qureshi
Contact
Hans Hammers
Principal Investigator
Next Oncology
San Antonio Texas, 78229, United States More Info
Cynthia DeLeon
Contact
210-580-9521
David Sommerhalder
Principal Investigator
Centre Antoine Lacassagne - Nice
Nice , 06189, France More Info
Christine Lovera
Contact
+33-4-92 03 16 18
Esma SAADA-BOUZID
Principal Investigator
IUCT Oncopole
Toulouse , 31059, France More Info
Iphigenie KORAKIS
Principal Investigator
Hadassah Medical Center
Jerusalem , 91120, Israel More Info
Jonathan Cohen
Principal Investigator
The Chaim Sheba Medical Center
Ramat Gan , 52621, Israel More Info
Contact
972-3-5304498
Talia Golan
Principal Investigator
Wakayama Medical University Hospital
Wakayama Kimiidera, 641-8, Japan More Info
Toshio Shimizu
Principal Investigator
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan More Info
Contact
81-335422511
Noboru Yamamoto
Principal Investigator
Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
Hye W Han
Contact
+82-2-6072-5224
Do-Youn Oh
Principal Investigator
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain More Info
Contact
34-917567825
Emiliano Calvo Aller
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

248

Study ID:

NCT04777994

Recruitment Status:

Recruiting

Sponsor:


Calico Life Sciences LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.