An Open, Multi-center Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Lung cancer remains the leading cause of cancer deaths worldwide; in 2022, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. Globally, lung cancer is the leading cause of cancer-related deaths in men and the second leading cause in women after breast cancer. Among them, small cell lung cancer (SCLC) accounts for approximately 14% of all newly diagnosed lung cancers. Small cell lung cancer (SCLC) is a highly heterogeneous and aggressive disease with poor survival outcomes.
A 2-stage system dividing patients into limited and extensive disease was developed in 1973 by the United States (US) Veteran's Administration Lung Cancer Study Group (VALG), which has been used to this day. Patients with limited-stage SCLC can be treated with chemotherapy and radiation with the potential for long-term survival. However, the majority (approximately 70%) of patients with SCLC are diagnosed with extensive-stage SCLC (ES-SCLC), which has poor survival prospects. Chest pain, dyspnea, and cough are among the most frequent disease-related symptoms experienced by patients with SCLC. Immune checkpoint inhibitors in combination with platinum-based systemic therapy can palliate symptoms and prolong survival for patients with ES-SCLC. However, long-term survival is rare.
The current standard first-line treatment for patients with ES-SCLC is immune checkpoint inhibitors in combination with platinum-based systemic therapy. Despite the impressive high objective response rates (approximately 60%-80%) observed with first-line treatment regimens, the median overall survival (OS) of patients rarely exceeds 16 months, and the median progression-free survival (PFS) is also limited to around 5 months. Second-line and subsequent therapeutic options are limited. The main treatment drugs include Topotecan, Lurbinectedin, Tarlatamab, etc., with objective response rates rarely exceeding 40%. Therefore, there is a significant need for improved novel treatment options for patients with ES-SCLC.
This is a multi-center, open-label study. The study is designed to evaluate the safety, tolerability, and preliminary efficacy of Toripalimab in combination with BL0020 in patients with ES-SCLC who have relapsed or progressed following first-line platinum-based systemic treatment regimen.

Start Date16 Jun 2026

Sponsor / Collaborator

Shanghai Best-Link Bioscience LLC

NCT07414927

/ Not yet recruitingPhase 1/2

An Open-Label, Single-Arm Phase I/II Clinical Study to Evaluate the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy

The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). After a certain period of treatment with EGFR TKI, acquired resistance emerges most frequently with a secondary mutation, p.T790M, followed by MET amplification. Interestingly, up to 3-14% of patients experience histological transformation into small cell lung cancer (SCLC), which has an aggressive clinical course and a poor prognosis.
The transformed SCLC retains the original EGFR mutation but significantly down regulates EGFR protein expression, eliminating its dependence on EGFR signaling while simultaneously acquiring a neuroendocrine phenotype. In nearly all cases, bi-allelic inactivation of both TP53 and RB1 is observed. However, little is known about the clinical outcomes of transformed SCLC, with limited studies arguing that their outcomes are similar to those of de novo SCLC, where the median overall survival is approximately 9 to 10 months after the transformation.
At present, there is no standard treatment regimen for patients with SCLC transformed from NSCLC following EGFR TKI therapy.
BL0020 is a polymer-drug conjugate consisting of Topoisomerase I inhibitor SN-38 (7-ethyl-10-hydroxycamptothecin) conjugated by a peptide linker to a PEG-modified poly(ε-L-lysine) polymer. In the ongoing first-in-human study of BL0020, significant efficacy has been observed with BL0020 monotherapy in SCLC patients who have relapsed or progressed following at least first-line platinum-based systemic treatment.
Based on previous clinical and preclinical outcomes that show similar disease characteristics between SCLC transformed from NSCLC following EGFR TKI therapy and de novo SCLC, this study is designed to evaluate the clinical efficacy and safety of BL0020 in patients with transformed SCLC.

Start Date27 Mar 2026

Sponsor / Collaborator

Shanghai Best-Link Bioscience LLC

NCT05886868

/ Unknown statusPhase 1

A Phase I, International, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BL0020 as A Single Agent in Patients With Advanced Solid Tumors

This is the first in human study of BL0020, and the primary objective is to evaluate the safety and tolerability, and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of BL0020 as a single agent in patients with advanced solid tumors.
This study consists of two parts: Part A (dose escalation stage) and Part B (dose expansion stage).
The study includes screening, treatment and follow-up periods.
In part A, "3+ 3" will be used for dose escalation.
In part B, the dose level and/or enrolled patient population for dose-expansion may be adjusted based on available data on the safety, PK and preliminary efficacy gained from the patients.

Start Date24 Oct 2023

Sponsor / Collaborator

Shanghai Best-Link Bioscience LLC

100 Clinical Results associated with BL-0020

100 Translational Medicine associated with BL-0020

100 Patents (Medical) associated with BL-0020

Literatures (Medical) associated with BL-0020

01 Jun 2024·European Journal of Oncology Nursing

Efficacy of acupuncture for a cough-related symptom cluster in patients with lung cancer: A randomized controlled trial

Article

Author: Ye, Zeng Jie ; Wei, Jia Hao ; Wu, Xiu Mei ; Zhang, Chun Xia ; Bu, Meng Ru ; Zhou, Jin ; Liao, Rong Rong

PURPOSE:

This study was designed to evaluate the effect of acupuncture on cough, expectoration, and shortness of breath in lung cancer patients.

METHODS:

Between December 2021 and June 2022, a total of 130 lung cancer patients were recruited, and they were split into control and intervention groups at random. Routine nursing was provided to the control group, whereas routine nursing with acupuncture using LU7 (Lie Que), LU9 (Tai Yuan), BL13 (Fei Shu), and BL20 (Pi Shu) was administered to the intervention group for 7 days. The severity of cough, expectoration, and shortness of breath was assessed 1 day before and after the interventions using the lung cancer-specific module of the MDASI. A two-way ANOVA was performed for group comparisons.

RESULTS:

Compared with the control group, the symptoms of cough in the intervention group were significantly improved (F = 5.095, MD = -0.32, 95% CI, -0.59 to 0.04, P = 0.025), while expectoration (F = 0.626, MD = -0.11, 95% CI, -0.38 to 0.16, P = 0.430) and shortness of breath (F = 0.165, MD = -0.05, 95% CI, -0.27 to 0.18, P = 0.685) had no significant change. Cough also identified an obvious interaction effect (P = 0.014), and the post-intervention simple main effect test demonstrated a tangible difference between the two groups (MD = -0.66, 95% CI, -0.99 to 0.33, P < 0.001) post-intervention.

CONCLUSIONS:

Acupuncture using LU7, LU9, BL13, and BL20 can relieve the cough of lung cancer patients, but not relieve expectoration and shortness of breath.

31 Oct 2022·Journal of acupuncture and meridian studies

Acupuncture for Osteoporosis: a Review of Its Clinical and Preclinical Studies

Review

Author: Tian, Yimiao ; Zhang, Dongwei ; Zhao, Dandan ; Zhu, Ruyuan ; Chen, Beibei ; Che, Yiwen ; Xu, Tianshu ; Zhang, Hao ; Li, Rui ; Wang, Lili ; Xia, Bingke

Acupuncture has gained growing attention in the management of osteoporosis (OP). However, a comprehensive review has not yet been conducted on the efficacy and challenges of acupuncture in preliminary research and clinical trials. Therefore, an extensive literature search was conducted using electronic databases, including PubMed (www.ncbi.nlm.nih.gov/pubmed), CNKI (www.cnki.net), and Web of Science, for studies published from the beginning of 2000 to the end of May 2022. Combinations of synonyms for OP, acupuncture, traditional Chinese medicine, clinical trial, preclinical study, and animal experiments were searched. A total of 290 papers were consulted, including 115 reviews, 109 clinical observations, and 66 preclinical studies. There is accumulating evidence to support the beneficial role of acupuncture in preserving bone quality and relieving clinical symptoms based on clinical and preclinical investigations. The top ten most commonly used acupoints are BL23, ST36, BL20, BL11, CV4, GV4, SP 6, KI3, BL18, and GB39. The underlying mechanisms behind the benefits of acupuncture may be linked with the regulation of the hypothalamic-pituitary-gonadal (adrenal) axis and activation of the Wnt/β-catenin and OPG/RANKL/RANK signaling pathways. In summary, strong evidence may still come from prospective and well-designed clinical trials to shed light on the potential role of acupuncture in preserving bone loss. Future investigations are needed to explore the potential underlying mechanisms, long-term clinical efficacy, and compliance of acupuncture in OP management.

28 Oct 2022·Medicine

Anatomical structures and needling method of the back-shu points BL18, BL20, and BL22 related to gastrointestinal organs: A PRISMA-compliant systematic review of acupoints and exploratory mechanism analysis

Review

Author: Ryu, Myungseok ; Han, Yaejin ; Han, Sihyun ; Cho, Yeonwoo ; Hongmin, Chu ; Chae, Hyocheong ; Kim, Yeji ; Oh, Kichang

Background::

Acupuncture treatment on back-shu points (BSPs) has received attention owing its ability to control the function of visceral organs. We aimed to conduct a systematic review to provide detailed information on the effectiveness and safety of BL18, BL20, and BL22 on the digestive system in terms of soft tissue and anatomical structure and assist in the appropriate application.

Methods::

Medline, Cochrane Library, EMBASE, OASIS, RISS, and CNKI were searched from their inception to July 2021. This systematic review included randomized controlled trials, controlled clinical trials, case series, and case reports that addressed anatomical structures or needling methods of BL18, BL20, and BL22.

Results::

In total, 115 articles were included from the 7 electronic databases. One hundred eight articles described the depth and method. A total of 96 articles described depth, 86 articles described the angle, and 74 articles described both. Seventy-nine articles described the target muscles and anatomical structure. Acupuncture on BSP is effective in gastrointestinal diseases because of compression of the spinal nerve, sympathetic nerve hyperactivity, and connection of the diaphragm. By reviewing each study’s acupuncture method and target muscles, we analyzed the angle and depth of the needle that effectively leads to therapeutic response.

Conclusions::

This study provides guidance on applying needles in terms of anatomical structures to yield therapeutic responses. However, few studies have assessed how to effectively stimulate BSP to trigger digestive effects and their mechanisms. Additional studies on the relationship between BSP and the digestive system are needed to use these acupoints for digestive diseases.

News (Medical) associated with BL-0020

19 May 2026

·endpoints.news

Full-Life Technologies raises $150M; Quince's reboot with pulmonary drug

Plus, news about Accro Bioscience, Hansa Biopharma, Shanghai Best-Link Bioscience and UCB. Full-Life Technologies gets $150M: The radiotherapy company has raised $110 million in a Series D round and another $40 million in debt financing. The company plans to use the Series D to fund its clinical stage assets, including its 225Ac-FL-020 for prostate cancer and its 225Ac-FL-261 candidate for multiple solid tumor indications. Full-Life will also use the funds to start manufacturing the radioisotope actinium-225 at its factory in Belgium. The financing was led by Vivo Capital, along with SK, Chengwei Capital, HSG, Junson Capital, Yunion, Plaisance, Sky9 Capital, TSG Capital and others. — Anna Brown Quince finds a new life: Public biotech Quince Therapeutics reverse-merged with private drug developer Orphai Therapeutics in a deal that includes $115 million upfront and up to $72 million additionally down the road. Well-known life sciences investors took part, including Cormorant, Foresite and others. In conjunction with the deal, Orphai disclosed Phase 2a data for its inhaled version of rapamycin in pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Quince had failed a Phase 3 in January, prompting the company to look for alternatives. — Kyle LaHucik China biotech gets $50M: Suzhou-based Accro Bioscience secured a Series C from OrbiMed, TCG Crossover, Lilly Asia Ventures, Shenzhen Capital Group and others. The company is working on regulated cell death and will use the money for a Phase 2b of its RIPK2 inhibitor, dubbed AC-101, in ulcerative colitis. Another biotech in that target space, Massachusetts and Michigan startup Odyssey Therapeutics, raised a $279 million IPO earlier this month. — Kyle LaHucik SERB Pharmaceuticals buys rights to Hansa Biopharma drug: The Belgian specialty pharma company will acquire the development and commercialization rights to Hansa’s Idefirix for €115 million ($127 million). The rights pertain to the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and the Middle East and North Africa region. The drug still needs to be filed with the European Medicines Agency, and Hansa will support SERB with that process. — Kyle LaHucik Best-Link Bioscience raises Series C: The Shanghai biotech collected a 400 million yuan ($58 million) funding round just five months after disclosing a 200 million yuan ($29 million) Series B. The five-year-old biotech is in Phase 2a in the US, China and Australia with a treatment candidate called BL0020 for small cell lung cancer. It also has a protein degrader named BL0175 in Phase 1 for breast cancer. — Kyle LaHucik UCB’s Bimzelx beats Skyrizi: The drugmaker said its medicine had superior joint outcomes at week 16 compared to AbbVie’s Skyrizi in adults with psoriatic arthritis. UCB said it was the first approved biologic to show statistically significant superiority on that measurement in a head-to-head trial in that indication. The data come after UCB made two acquisition announcements in recent weeks. — Kyle LaHucik

Phase 2AcquisitionDrug ApprovalIPOPhase 1

100 Deals associated with BL-0020

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	Phase 2	China	Shanghai Best-Link Bioscience LLC	27 Mar 2026
Small Cell Lung Cancer	Phase 2	China	Shanghai Best-Link Bioscience LLC	13 Feb 2026
Extensive stage Small Cell Lung Cancer	Phase 1	China	Shanghai Best-Link Bioscience LLC	06 May 2026
Advanced Malignant Solid Neoplasm	Phase 1	Australia	Shanghai Best-Link Bioscience LLC	17 Oct 2023
Pancreatic Cancer	Phase 1	Australia	Shanghai Best-Link Bioscience LLC	17 Oct 2023
Triple Negative Breast Cancer	Phase 1	Australia	Shanghai Best-Link Bioscience LLC	17 Oct 2023
Solid tumor	IND Approval	United States	Shanghai Best-Link Bioscience LLC	30 Nov 2023

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