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INCLINE-101: A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=72, Active, not recruiting, Tallac Therapeutics | Recruiting --> Active, not recruiting | N=200 --> 72
Enrollment closed • Enrollment change • Metastases
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mozistobart zoratolimod (TAC-001)
1year
INCLINE-101: preliminary safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TAC-001 (TLR9 agonist conjugated to a CD22 mAb) in patients with advanced or metastatic solid tumors (SITC 2023)
Two of eight response evaluable pts have stable disease and remain on study (range 5+ to 10+ months). Conclusions TAC-001 appears well tolerated with dose dependent PK and PD activity consistent with the proposed proof of mechanism - evaluation & enrollment is ongoing.
Clinical • PK/PD data • PD(L)-1 Biomarker • IO biomarker • Metastases
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CD22 (CD22 Molecule)
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mozistobart zoratolimod (TAC-001)
2years
Clinical • P1/2 data • IO biomarker
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CD22 (CD22 Molecule)
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mozistobart zoratolimod (TAC-001)
over3years
[VIRTUAL] TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells, promotes anti-tumor immunity and favorable safety profile following systemic administration in preclinical models (AACR 2021)
These results demonstrate the unique properties of TAC-001 which integrates TLR9 activation and B cells to employ both innate and adaptive immune responses to promote anti-tumor activity. These data support the development of TAC-001 for a broad range of solid tumor malignancies.
Preclinical • PD(L)-1 Biomarker • IO biomarker
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PD-1 (Programmed cell death 1) • IL10 (Interleukin 10)
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mozistobart zoratolimod (TAC-001)