NCT04244552

A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies

Terminated Phase 1 Last updated 29 December 2023

What this trial tests

Phase 1 trial testing ATRC-101 in Breast Cancer in 87 participants. Terminated before completion.

Timeline

11 February 2020

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	Atreca, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	87
Start date	11 February 2020
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	19 locations across United States

Drugs / interventions tested

• ATRC-101 — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Pegylated liposomal doxorubicin (PLD) (pegylated-liposomal-doxorubicin-pld) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Ovarian Cancer — all drugs for Ovarian Cancer →
• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

Atreca, Inc. — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

ATRC-101-A01 is a Phase 1b, open-label dose escalation and expansion trial of ATRC-101, an engineered fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally occurring human antibody. The safety, tolerability, PK, and biological activity of ATRC-101 will be characterized when administered every two weeks (Q2W) or every 3 weeks (Q3W) as a monotherapy or in combination with other anticancer agents.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Skin cancer: understanding the journey of transformation from conventional to advanced treatment approaches.
   Hasan N, Nadaf A, Imran M, Jiba U, et al · · 2023 · cited 117× · PMID 37803407 · DOI 10.1186/s12943-023-01854-3
2. Unraveling Resistance to Immunotherapy in MSI-High Colorectal Cancer.
   Heregger R, Huemer F, Steiner M, Gonzalez-Martinez A, et al · · 2023 · cited 32× · PMID 37894457 · DOI 10.3390/cancers15205090
3. Acral melanoma: new insights into the immune and genomic landscape.
   Carvalho LAD, Aguiar FC, Smalley KSM, Possik PA. · · 2023 · cited 21× · PMID 37913653 · DOI 10.1016/j.neo.2023.100947
4. Immune Biomarkers in Triple-Negative Breast Cancer: Improving the Predictivity of Current Testing Methods.
   Porta FM, Sajjadi E, Venetis K, Frascarelli C, et al · · 2023 · cited 19× · PMID 37511789 · DOI 10.3390/jpm13071176
5. Advances in nanomaterials for the diagnosis and treatment of head and neck cancers: A review.
   Yu C, Li L, Wang S, Xu Y, et al · · 2023 · cited 19× · PMID 37056270 · DOI 10.1016/j.bioactmat.2022.08.010
6. Pharmacological impact of microRNAs in head and neck squamous cell carcinoma: Prevailing insights on molecular pathways, diagnosis, and nanomedicine treatment.
   Bhattacharjee B, Syeda AF, Rynjah D, Hussain SM, et al · · 2023 · cited 17× · PMID 37205904 · DOI 10.3389/fphar.2023.1174330
7. Electroporation in Head-and-Neck Cancer: An Innovative Approach with Immunotherapy and Nanotechnology Combination.
   Pisani S, Bertino G, Prina-Mello A, Locati LD, et al · · 2022 · cited 17× · PMID 36358782 · DOI 10.3390/cancers14215363
8. MicroRNAs with Multiple Targets of Immune Checkpoints, as a Potential Sensitizer for Immune Checkpoint Inhibitors in Breast Cancer Treatment.
   Zhou H, Jia W, Lu L, Han R. · · 2023 · cited 16× · PMID 36765782 · DOI 10.3390/cancers15030824