Clinical Trials

Clinical Trials

CBP-1008

FRα/TRPV6 , PROC/OCCC ,Phase II MRCT
NCT04740398

CBP-1008 has been developed utilizing our first-generation Bi-XDC platform technology.
It represents a pioneering Bi-XDC targeting FRα and TRPV6, with monomethyl auristatin E (MMAE) as payload.
In contrast to ADCs, Bi-XDCs exhibit smaller molecular sizes, enhanced tissue permeability, lower immunogenicity, shorter elimination half-lives, and reduced manufacturing costs. Moreover, the synergistic effect of the bi-specific ligands in CBP-1008 notably enhances drug delivery performance. Preclinical studies have demonstrated promising therapeutic efficacy against ovarian cancer (OC), triple-negative breast cancer (TNBC), and other solid tumors.

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CBP-1018

FRα/PSMA, mCRPC, Phase I trial
NCT04928612
CBP-1018, a bi-specific ligand conjugated molecule targeting FRα and PSMA receptors, is the second product developed by our Bi-XDC platform technology. The molecule incorporates an optimized bi-ligand system, an enzyme-cleavable trifunctional linker, and a cytotoxin MMAE payload.
CBP-1018 demonstrates a superior preclinical therapeutic window, improved drug uptake, enhanced plasma stability, and increased solubility. In proof-of-concept studies, CBP-1018 exhibited remarkable antitumor efficacy in lung and prostate preclinical models, supporting the underlying molecular rationale.
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CBP-1019

FRα/TRPV6,Phase I/II MRCT,ODD
NCT05830097

CBP-1019, the next generation bi-specific ligand conjugated compound targeting FRα/TRPV6 receptors with topoisomerase 1 inhibitor derivative payload, is developed by our second-generation Bi-XDC platform technology.
Compared to the first generation, the Bi-XDC platform in CBP-1019 incorporates an improved tri-functional linker design. This linker offers greater stability in plasma, making it more suitable for conjugates with small molecular weights and enabling more efficient conjugation. Pre-clinical studies using PDX models (e.g., gynecological tumors, lung cancer, gastrointestinal tumors) demonstrate that CBP-1019 exhibits excellent efficacy with a dose-correlation trend. Notably, the safety profile is also excellent, with minimal body weight loss observed in study animals even at the highest dose tested.

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CBP-1008

CBP-1008 has been developed utilizing our first-generation Bi-XDC platform technology.

It represents a pioneering Bi-XDC targeting FRα and TRPV6, with monomethyl auristatin E (MMAE) as payload. In contrast to ADCs, Bi-XDCs exhibit smaller molecular sizes, enhanced tissue permeability, lower immunogenicity, shorter elimination half-lives, and reduced manufacturing costs. Moreover, the synergistic effect of the bi-specific ligands in CBP-1008 notably enhances drug delivery performance. Preclinical studies have demonstrated promising therapeutic efficacy against ovarian cancer (OC), triple-negative breast cancer (TNBC), and other solid tumors.

Two Phase I clinical trials have been completed with manageable safety profiles, yet have not reached the maximum tolerated dose (MTD). Ongoing Phase 2 clinical trial demonstrated promising efficacy and favorable safety profile. We are highly confident in the upcoming pivotal trial for advanced platinum-resistant ovarian cancer (PROC). The multi-regional clinical trial (MRCT) in patients with recurrent or persistent platinum-resistant ovarian clear cell carcinoma (OCCC) is currently under FDA communication and is poised to commence shortly.

In the near future, the combination of CBP-1008 with immunotherapy (PD-1/PD-L1), chemotherapy (platinum) or targeted therapy (bevacizumab, PARP inhibitors) could be explored. Due to compelling safety and efficacy data, CBP-1008 has been selected for both an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) and a poster presentation at 2023 ASCO. Additionally, CBP-1008 is in the process of applying for Orphan Drug Designation (ODD) for OCCC and Breakthrough Therapy Designation (BTD) for PROC.

CBP-1018

CBP-1018, a bi-specific ligand conjugated molecule targeting FRα and PSMA receptors, is the second product developed by our Bi-XDC platform technology. The molecule incorporates an optimized bi-ligand system, an enzyme-cleavable trifunctional linker, and a cytotoxin MMAE payload.

CBP-1018 demonstrates a superior preclinical therapeutic window, improved drug uptake, enhanced plasma stability, and increased solubility. In proof-of-concept studies, CBP-1018 exhibited remarkable antitumor efficacy in lung and prostate preclinical models, supporting the underlying molecular rationale.

CBP-1018 received regulatory approval for conducting its first-in-human Phase I clinical trial in both China and the United States accordingly. The dose-escalation stage demonstrated a manageable safety profile, with no maximum tolerated dose (MTD) identified, and encouraging early signs of efficacy. Based on these positive results, the dose/cohort expansion stage is ongoing to evaluate the clinical potential of CBP-1018 in patients with metastatic castration-resistant prostate cancer (mCRPC), renal cell carcinoma (RCC), and lung cancer (LC). Additionally, a combination therapy plan with next-generation hormonal agents (NHAs) for mCRPC is under development.

CBP-1018 has garnered significant attention at various global conferences, including presentations at the 2022 American Society of Clinical Oncology (ASCO), the 2023 European Society for Medical Oncology (ESMO), and the 2023 2nd Next-Generation Conjugates Summit.

CBP-1019

CBP-1019, the next generation bi-specific ligand conjugated compound targeting FRα/TRPV6 receptors with topoisomerase 1 inhibitor derivative payload, is developed by our second-generation Bi-XDC platform technology.

Compared to the first generation, the Bi-XDC platform in CBP-1019 incorporates an improved tri-functional linker design. This linker offers greater stability in plasma, making it more suitable for conjugates with small molecular weights and enabling more efficient conjugation. Pre-clinical studies using PDX models (e.g., gynecological tumors, lung cancer, gastrointestinal tumors) demonstrate that CBP-1019 exhibits excellent efficacy with a dose-correlation trend. Notably, the safety profile is also excellent, with minimal body weight loss observed in study animals even at the highest dose tested.

CBP-1019 is currently under investigation in two clinical trials. A Phase I/II multi-regional clinical trial (MRCT) is evaluating its efficacy and safety in patients with advanced solid tumors. Additionally, a separate Phase I clinical trial is assessing CBP-1019 in patients with advanced thoracic tumors. Early data from these trials, particularly in patients with advanced platinum-resistant ovarian cancer (PROC), is encouraging. CBP-1019 has demonstrated good efficacy and a favorable safety profile, with no ILD (interstitial lung disease) which is commonly observed in other antibody-drug conjugate (ADC) therapies.In recognition of its potential benefit, CBP-1019 was granted Orphan Drug Designation (ODD) for pancreatic cancer,esophagus cancer and small cell lung cancer by FDA.Development of combination therapies with CBP-1019 is also ongoing.